FRO
Class U
Unknown Device Classification Codes
2978 FDA 510(k) clearances across 898 product codes.
EFQ
Class U
Gauze/Sponge, Internal
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KGN
Class U
Wound Dressing With Animal-Derived Material(S)
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LFL
Class U
Instrument, Ultrasonic Surgical
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MGQ
Class U
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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QSY
Class U
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
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LCM
Class U
Enzyme Immunoassay, Phencyclidine
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MGP
Class U
Dressing, Wound And Burn, Occlusive
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MRW
Class U
System, Facet Screw Spinal Device
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HPX
Class U
Lens, Contact (Polymethylmethacrylate)
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MQC
Class U
Mouthguard, Prescription
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LJE
Class U
Catheter, Nephrostomy
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LCJ
Class U
Tissue Expander And Accessories
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LFD
Class U
Saliva, Artificial
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LQY
Class U
Locator, Root Apex
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LZU
Class U
Plug, Punctum
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OBR
Class U
Mouthguard, Over-The-Counter
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OLR
Class U
Oral Wound Dressing
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KJJ
Class U
Cleanser, Root Canal
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MTJ
Class U
Wax, Bone
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MVL
Class U
Cord, Retraction
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LXM
Class U
Manipulator, Plunger-Like Joint
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OKS
Class U
Lacrimal Stents And Intubation Sets
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LIL
Class U
Monitor, Penile Tumescence
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MLY
Class U
Vapocoolant Device
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LHD
Class U
Device, Fertility Diagnostic, Proceptive
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LKB
Class U
Pad, Alcohol, Device Disinfectant
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LKN
Class U
Separator, Automated, Blood Cell And Plasma, Therapeutic
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LXV
Class U
Apparatus, Vestibular Analysis
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NLQ
Class U
Single-Use Reprocessed Ultrasonic Surgical Instruments
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LYX
Class U
Media, Corneal Storage
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BWK
Class U
Stimulator, Electro-Acupuncture
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QSZ
Class U
Absorbable Synthetic Wound Dressing
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LKX
Class U
Device, Thermal, Hemorrhoids
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MVO
Class U
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
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QSX
Class U
Hemostatic Wound Dressing With Thrombin Or Other Biologics
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MOT
Class U
Irradiator, Blood To Prevent Graft Versus Host Disease
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LRR
Class N
First Aid Kit With Drug
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LWM
Class U
Device, Electrical Dental Anesthesia
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EWD
Class U
Protector, Hearing (Insert)
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LXC
Class U
Monitor, Pressure, Intracompartmental
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LFB
Class U
Button, Nasal Septal
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MRD
Class U
Mammary Sizer
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MVV
Class U
Device, Acupressure
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LCL
Class U
Radioimmunoassay, Phencyclidine
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LAO
Class U
Enzyme Immunoassay, Methotrexate
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LZJ
Class U
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
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LQD
Class U
Recorder, Attention Task Performance
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KTA
Class U
Medium, Contrast, Radiologic
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LDK
Class U
Device, Sensing, Optical Contour
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LRA
Class U
Hearing Aid, Tactile
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LBK
Class U
Neurosurgical Ultrasonic Instruments
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LPZ
Class U
Container, Frozen Donor Tissue Storage
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LRQ
Class 1
Tracheostomy And Nasal Suctioning Kit
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MJV
Class U
Device, Inflation, Middle Ear
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NVR
Class 3
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
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SEJ
Class U
Wound Dressings Containing Topical Analgesics
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LKW
Class 3
Laser, Neurosurgical
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LZW
Class U
Monitor, Spine Curvature
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NQK
Class U
Maggots, Medical
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LLF
Class 3
Laser, Neurosurgical, Argon
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MQZ
Class U
Prosthesis, Nail
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OHA
Class U
Heart Valve, More Than Minimally Manipulated Allograft
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PHN
Class U
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
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LEZ
Class U
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
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LRL
Class U
Cushion, Hemorrhoid
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LWE
Class 2
Bone Marrow Collection/Transfusion Kit
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LXQ
Class U
Cup, Eye
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MJT
Class 3
Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
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OCO
Class U
Mouthguard, Migraine/Tension Headache
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SEL
Class U
Securement Wound Dressing For Reduction Of Infection
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ESI
Class 3
Polymer, Natural-Absorbable Gelatin Material
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FAG
Class 3
Prosthesis, Urethral Sphincter
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LFA
Class U
Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
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LLE
Class 3
Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
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LQB
Class 3
Medical Computers And Software For Ophthalmic Use
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LTD
Class 3
Paraquat Assay
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LWZ
Class 3
Tissue Graft Of Less Than 6mm
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MIG
Class U
Strip, Test Isoniazid
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PHU
Class U
Intra-Abdominal Pressure Monitoring Device
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SEK
Class U
Wound Dressings With Hydrocortisone
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EWE
Class U
Protector, Hearing (Circumaural)
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EZZ
Class 3
Prosthesis, Vas Deferens
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FAA
Class 3
Replacer, Urethral
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HMN
Class 3
Suture, Nonabsorable, Ophthalmic
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KGF
Class 3
Adhesive, Tissue For Aneurysmorrhaphy
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LME
Class 3
Monitor, Blood-Flow, Cerebral, Thermal Diffusion
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LMQ
Class 3
Device, Peritoneal Access, Subcutaneous, Implanted
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LNL
Class U
Stimulator, Electrical For Sperm Collection
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LOI
Class 3
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
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LQQ
Class 3
Columns, Immunoadsorption In Extracorporeal Systems
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LQS
Class U
Spermatocele, Alloplastic
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LTC
Class 3
Hyaline Membrane Disease Assay
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LXW
Class 3
Column, Adsorption, Low Density, Lipoprotein
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MBJ
Class 3
Fastener, Fixation, Biodegradable, Hard Tissue
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MGI
Class 3
Aspirator, Ultrasonic
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MHZ
Class 3
Stimulator, Vestibular Acceleration, Therapeutic
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MSI
Class 3
Solution, Cleaning / Lubricating, Artificial Eye
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NRN
Class U
Leeches, Medicinal
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OIH
Class U
Yersinia Spp. Reagents
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BSD
Class 3
Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling
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DSQ
Class 3
Ventricular (Assist) Bypass
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DTH
Class 3
Suture, Cardiovascular
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DZG
Class 3
Suture, Dental
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EPG
Class 3
Stimulator, Transdermal
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FAB
Class 3
Replacer, Ureteral
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FAC
Class 3
Valve, Ureterovesicle
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FAO
Class 3
Device, Cystometric, Air
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FBY
Class 3
Cooler, Esophageal And Gastric
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FBZ
Class 3
Cooler, Prostatic
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FZC
Class 3
Prosthesis, Arterial Graft, Bovine Carotid Artery
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HHY
Class 3
Prosthesis, Suture, Cerclage
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HMO
Class 3
Suture, Absorbable, Ophthalmic
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HTM
Class 3
Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive
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HWF
Class 3
Prosthesis, Ligament
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KGG
Class 3
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
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KGM
Class 3
Silicone, Liquid, Injectable
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KSJ
Class 3
System, Identification, Hepatitis B Antigen
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KTJ
Class 3
System, Test, Alpha-Fetoprotein, Ria
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LEI
Class 3
Implant, Anti-Gastroesophageal Reflux
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LGW
Class 3
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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LHE
Class 3
Controller, Closed-Loop Blood Glucose
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LHY
Class 3
Electrode, Stabilized Epidural Spinal
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LII
Class 3
Monitor, Intracranial Pressure, Implanted
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LIW
Class U
Fibrillator, Ac
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LKK
Class 3
Pump, Infusion, Implanted, Programmable
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LKV
Class 3
Enzyme Immunoassay, Fetal Fibronectin
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LLP
Class 3
Laser For Pain Therapy
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LLQ
Class 3
Cap, Cervical, Contraceptive
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LLX
Class 3
Catheter, Sampling, Chorionic Villus
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LMH
Class 3
Implant, Dermal, For Aesthetic Use
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LMI
Class 3
Implant, Collagen For Non-Aesthetic Use
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LML
Class 3
Ligaments And Tendons, Synthetic
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LMN
Class 3
Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses
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LMW
Class 3
Solution, Removal, Carries
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LMY
Class 3
Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
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LMZ
Class 3
Applicator, Hyperthermia, Interstitial
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LNB
Class 3
Applicator, Hyperthermia, Deep Heating, Ultrasound
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LNC
Class 3
Applicator, Hyperthermia, Superficial, Rf/Microwave
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LNM
Class 3
Agent, Bulking, Injectable For Gastro-Urology Use
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LNQ
Class f
Intestinal Stimulator
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LNR
Class 3
System, Photopheresis, Extracorporeal
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LNY
Class 3
Catheter, Percutaneous, Long Term, Intraspinal
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LOA
Class 3
Device, Testicular Hypothermia
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LOB
Class 3
Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
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LOC
Class 3
System, Rf/Microwave Hyperthermia, Cancer Treatment
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LOE
Class 3
Stimulator, Invasive Bone Growth
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LOG
Class 3
Catheter, Balloon For Retinal Reattachment
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LOH
Class 3
System, Identification, Contact Lens
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LOK
Class 3
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
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LOT
Class 3
Pulse-Generator, Program Module
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LOZ
Class 3
Artificial Heart
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LPA
Class 3
System, Esophageal Pacing
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LPB
Class 3
Cardiac Ablation Percutaneous Catheter
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LPC
Class 3
Device, Angioplasty, Laser, Coronary
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LPF
Class 3
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented
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LPG
Class 3
Material, Dressing, Surgical, Polylactic Acid
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LQE
Class 3
Implant, Corneal, Refractive
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LQI
Class 3
Hepatitis Delta Serological Reagents
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LSX
Class 3
Controller, Closed-Loop, Blood-Pressure
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LSY
Class 3
Ultrasound, Hyperthermia, Cancer Treatment
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LSZ
Class 3
Ventilator, High Frequency
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LTA
Class 3
Fluid, Hysteroscopy
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LTG
Class 3
Paste, Injectable For Vocal Cord Augmentation
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LTI
Class 3
Implant, Intragastric For Morbid Obesity
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LTQ
Class 3
Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
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LTY
Class 3
Fluid, Cytological Collection
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LWA
Class 3
Prosthesis, Ligament, Ptfe
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LWB
Class 3
Stimulator, Functional Neuromuscular, Scoliosis
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LWO
Class 3
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
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LWP
Class 3
Implantable Pulse Generator, Pacemaker (Non-Crt)
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LWQ
Class 3
Heart-Valve, Mechanical
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LWR
Class 3
Heart-Valve, Non-Allograft Tissue
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LWS
Class 3
Implantable Cardioverter Defibrillator (Non-Crt)
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LWT
Class 3
Occluder, Balloon, Vena-Cava
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LWW
Class 3
Pulse-Generator, Single Chamber, Single
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LWX
Class 3
Device. Laser Peripheral Angioplasty
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LXA
Class 3
Tissue Graft Of 6mm And Greater
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LXU
Class 3
Laser For Wound Healing
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LXY
Class 3
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Polymer/Metal/Polymer
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LYI
Class 3
Stimulator, Subcortical, Implanted For Epilepsy
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LYJ
Class 3
Stimulator, Autonomic Nerve, Implanted For Epilepsy
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LZQ
Class 3
Tissue Adhesive For Ophthalmic Use
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LZS
Class 3
Excimer Laser System
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MAD
Class 3
Catheter, Percutaneous (Valvuloplasty)
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MAE
Class 3
Occluder, Patent Ductus, Arteriosus
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MAF
Class 3
Stent, Coronary
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MAN
Class 3
Assay, Interleukin
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MAO
Class U
Dna-Probe, Human Chromosome
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MAQ
Class 3
Kit, Dna Detection, Human Papillomavirus
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MBD
Class 3
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
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MBQ
Class 3
Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
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MBS
Class 3
Filler, Bone Void, Non-Osteoinduction
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MBX
Class 3
Stimulator, Thalamic, Epilepsy, Implanted
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MCI
Class 3
Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
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MCL
Class 3
Kit, Test, In Vitro Periodontal
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MCM
Class 3
Implant, Cochlear
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MCN
Class 3
Barrier, Absorbable, Adhesion
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MCP
Class 3
Stimulator, Fetal, Acoustic
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MCV
Class 3
Spinal Pedicle Screw, Fixation, Appliance System
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MCX
Class 3
Catheter, Coronary, Atherectomy
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MDD
Class 3
Device, Dermal Replacement
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MDP
Class 3
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
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MDS
Class 3
Sensor, Glucose, Invasive
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MEQ
Class 3
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
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MER
Class 3
Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
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MES
Class 3
Stent, Urethral, Bulbous, Permanent Or Semi-Permanent
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MFA
Class 3
Device, Removal, Pacemaker Electrode, Percutaneous
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MFE
Class 3
Agent, Injectable, Embolic
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MFR
Class f
Stimulator, Brain, Implanted, For Behavior Modification
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MGB
Class 3
Device, Hemostasis, Vascular
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MGR
Class 3
Dressing, Wound And Burn, Interactive
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MGX
Class 3
Test System, For Drugs Of Abuse
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MHE
Class 3
Implant, Auditory Brainstem
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MHR
Class 3
Test, Anti-Tumor Cell Susceptibility
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MHY
Class 3
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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MIE
Class 3
Heart-Valve, Allograft
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MIH
Class 3
System, Endovascular Graft, Aortic Aneurysm Treatment
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MIK
Class 3
Device, Ultrasonic, Thermal Ablation
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MIP
Class 3
Implanted Fecal Incontinence Device
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MIR
Class 3
Shunt, Portosystemic, Endoprosthesis
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MJB
Class 3
Antigen, Cancer 549
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MJO
Class 3
Prosthesis, Intervertebral Disc
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MJS
Class 3
Contrast Media, Ultrasound
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MKD
Class 3
Stimulator, Functional Walking Neuromuscular, Non-Invasive
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MKN
Class 3
Catheter, Balloon, Transcervical
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MKQ
Class 3
Processor, Cervical Cytology Slide, Automated
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MLQ
Class 3
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
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MLV
Class 3
Transcatheter Septal Occluder
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MMA
Class 3
Oximeter, Fetal Pulse
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MMY
Class 3
Lipoprotein, Low Density, Removal
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MNB
Class 3
Device, Thermal Ablation, Endometrial
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MNM
Class 3
Reader, Cervical Cytology Slide, Automated
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MNO
Class 3
System, Laser, Transmyocardial Revascularization
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MNQ
Class 3
Stimulator, Hypoglossal Nerve, Implanted, Apnea
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MOA
Class 3
Analyzer, Diagnostic, Fiber Optic (Colon)
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MOM
Class 3
System, Hemodynamic, Implantable
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MOU
Class 3
Intravascular Radiation Delivery System
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MOZ
Class 3
Acid, Hyaluronic, Intraarticular
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MPK
Class f
Semi-Constrained Metal/Polymer Finger Joint Prosthesis
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MPR
Class f
Stent, Bladder, Fetal
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MPV
Class 3
Implant, Hearing, Active, Middle Ear, Partially Implanted
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MPW
Class 3
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
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MQO
Class N
Prosthetic Disc Nucleus Device
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MQT
Class 3
Pump, Drug Administration, Closed Loop
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MRA
Class 3
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
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MRE
Class 3
Solution, Sodium Hyaluronate
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MRJ
Class 3
Ring, Endocapsular
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MRK
Class 3
System, Imaging, Fluorescence
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MRM
Class 3
Defibrillator, Implantable, Dual-Chamber
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MRU
Class f
Implanted Subcortical Electrical Stimulator (Motor Disorders)
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MSK
Class N
Immunoassay For Blood Tacrolimus
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MTA
Class 3
Lens, Intraocular, Phakic
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MTE
Class 3
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
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MTF
Class 3
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
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MTG
Class 3
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
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MTH
Class N
Tray, Leukocyte Typing
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MTI
Class N
Kit, Cell Screening, Fetal
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MTK
Class 3
Kit, Sample Collection, Hiv
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MTL
Class 3
Monitor,Test,Hiv-1
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MTN
Class N
Test, Syphilis, Treponemal
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MTO
Class N
Software, Management, Microplate Assay
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MTP
Class 3
Antibody To Htlv-1, Elisa
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MTQ
Class N
Software, Blood Virus Applications
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MTR
Class 2
Progenitor Cell Enumeration
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MTS
Class N
Vials, Challenge, Endotoxin
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MUQ
Class 3
Glue, Surgical, Arteries
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MUR
Class 3
Graft, Sclera, Reinforcement
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MUZ
Class 3
Stimulator, Autonomic Nerve, Implanted (Depression)
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MVC
Class 3
System, Test, Her-2/Neu, Ihc
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MVF
Class 3
System, Laser, Photodynamic Therapy
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MVG
Class 3
System, Laser, Fiber Optic, Photodynamic Therapy
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MVK
Class 3
Wearable Automated External Defibrillator
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MVW
Class N
Kit, Western Blot, Hiv-1
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MVX
Class N
Antibody, Monoclonal Blocking, Hiv-1
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MVY
Class N
Monoclonal, Hiv-1
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MVZ
Class 3
System, Test, Home, Hiv-1
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MWB
Class 3
Kit, Test, Saliva, Hiv-1&2
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MWD
Class 3
Electrosurgical, Radio Frequency, Refractive Correction
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MWG
Class 3
System, Oxygen, Aqueous
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MWH
Class f
Pulmonic Valved Conduit
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MWM
Class 3
Sensor, Electro-Optical (For Cervical Cancer)
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MWO
Class N
Reagent, Blood Bank, Quality Control
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MWQ
Class 3
System, Test, Total Antioxidant Status
View devices →
MXM
Class 3
Cap, Cooling (Infants)
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MXQ
Class 3
Stent, Urethral, External Sphincter, Permanent
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MYH
Class 3
System, Non-Coherent Light, Photodynamic Therapy
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MYK
Class N
Kit, Cord Blood Collection
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MYL
Class 3
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
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MYM
Class 3
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
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MYP
Class 2
Test, Platelet Antibody
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MYS
Class N
Device, Ahf, Automated Cryoprecipitation
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MYW
Class N
Irradiation, Blood Indicators
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MYY
Class 1
Separator, Semi-Automated, Blood Component
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MYZ
Class 2
Kit, Test (Donors), For Bloodborne Pathogen
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MZA
Class N
Test, Equipment, Automated Bloodborne Pathogen
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MZE
Class 2
Test, Donor, Cmv
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MZH
Class N
Test, Quantitative, For Hla, Non-Diagnostic
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MZI
Class U
Test, Qualitative, For Hla, Non-Diagnostic
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MZK
Class 3
System, Separation, Hematopoietic Stem Cell
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MZL
Class N
Kit, Test, Quality Control For Endotoxin
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NAF
Class 3
Antigen(Complexed),Prostate Specific,(Cpsa)
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NAH
Class 3
System, Test, Tumor Marker, For Detection Of Bladder Cancer
View devices →
NAN
Class 3
Tester, Acoustic, Bone Quality
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NAP
Class N
Cardiac Support Mesh Wrap
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NAV
Class f
Graft, Bypass, Coronary Artery
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NAW
Class 3
Microspheres Radionuclide
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NAZ
Class f
Stimulator, Bladder
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NBE
Class 3
Sealant, Polymerizing
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NBF
Class f
Prosthesis, Retinal
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NBN
Class 3
Generator, Shock-Wave, For Pain Relief
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NCD
Class 3
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
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NCJ
Class 3
Telescope, Implantable, Miniature
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NCL
Class 3
Imager, Breast, Electrical Impedance
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NCO
Class 3
Implant, Cartilage, For Articular Cartilage Repair
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NCT
Class 3
Instrument, Glucose, Noninvasive Technology
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NCV
Class 3
Lithotripter, Shockwave (For Treating Gallbladder Stones)
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NDV
Class f
Test, Ecarin Clotting Time (Ect)
View devices →
NEG
Class 3
Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
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NEK
Class 3
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
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NGM
Class U
Test, Phencyclidine (Pcp), Over The Counter
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NGV
Class 3
System, Appendage Closure, Left Atrial
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NHL
Class 3
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
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NIK
Class 3
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
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NIM
Class 3
Stent, Carotid
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NIN
Class 3
Stent, Renal
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NIO
Class 3
Stent, Iliac
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NIP
Class 3
Stent, Superficial Femoral Artery
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NIQ
Class 3
Coronary Drug-Eluting Stent
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NIU
Class 3
Stent, Superficial Femoral Artery, Drug-Eluting
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NIV
Class f
Coronary Covered Stent
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NJE
Class f
Intracranial Neurovascular Stent
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NJK
Class 3
Valve, Pulmonary
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NJL
Class 3
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
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NKE
Class 3
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
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NKM
Class 3
Mitral Valve Repair Devices
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NOX
Class 3
Filler, Bone Void, Synthetic Peptide
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NPE
Class 3
Material, Embolization, Neurovascular, Polymerizing Or Precipitating
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NPS
Class 3
Tricuspid Valve Repair Device, Percutaneously Delivered
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NPT
Class 3
Aortic Valve, Prosthesis, Percutaneously Delivered
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NPU
Class 3
Prosthesis, Mitral Valve, Percutaneously Delivered
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NPV
Class f
Pulmonary Valve Prosthesis Percutaneously Delivered
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NPW
Class 3
Percutaneously Delivered Prostheses And Tricuspid Valves
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NQC
Class f
Test, Breath Analysis, Volatile Organic Compounds
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NQO
Class 3
Prosthesis, Spinous Process Spacer/Plate
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NQR
Class 3
Sealant, Dural
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NRA
Class 3
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
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NRZ
Class 3
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
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NSD
Class 3
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
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NSJ
Class N
Restoration, Noble Metal
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NSK
Class N
Dentures, Partial
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NSL
Class N
Dentures, Full
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NSM
Class N
Restoration, Resin
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NSN
Class N
Restoration, Resin, Crown And Bridge
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NSO
Class N
Restoration, Porcelain-Fused-To-Metal
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NSP
Class N
Restoration, Porcelain
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NSQ
Class N
Restoration, Base Metal
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NSR
Class N
Prosthesis, Orthodontic
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NSS
Class N
Electronic Media, Nausea
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NTG
Class 3
Prosthesis, Ankle, Uncemented, Non-Constrained
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NUK
Class N
For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
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NUL
Class N
For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
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NVN
Class 3
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
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NVY
Class 3
Permanent Defibrillator Electrodes
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NVZ
Class 3
Pulse Generator, Permanent, Implantable
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NWX
Class 3
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
View devices →
NWY
Class N
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
View devices →
NXG
Class 3
Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
View devices →
NXJ
Class N
Denture, Cosmetic Only
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NXT
Class 3
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
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NXW
Class 3
Scaffold, Infrapopliteal, Absorbable
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NZC
Class 3
Stent, Urethral, Prostatic, Semi-Permanent
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NZF
Class N
Static Electricity-Emitting Device, Cosmetic Use
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NZK
Class 3
Stimulator, Low Electric Field, Tumor Treatment
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OAA
Class N
Aid, Visual, For Nausea
View devices →
OAD
Class 3
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
View devices →
OAE
Class 3
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
View devices →
OAF
Class 3
Implant, Hearing, Active, Middle Ear, Totally Implanted
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OAQ
Class N
Electronic Media, Hyperacusis
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OAW
Class f
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma
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OAY
Class 3
Light Source System, Diagnostic Endoscopic
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OAZ
Class f
One-Way Air-Leak Valve
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OBA
Class f
Polymerizing, Neurovascular Embolization Material
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OBC
Class 3
Occluder, Internal Vessel, Temporary
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OBD
Class 3
Barrier, Adhesion, Cardiovascular
View devices →
OCB
Class 3
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
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OCE
Class f
Cultured Epithelial Autograft
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OCK
Class 3
Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
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OCM
Class 3
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
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ODH
Class f
Implantable Bladder-Evacuation Electrical Stimulation System
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ODK
Class f
Refractive Corneal Implant
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ODS
Class f
Wound Covering (Composite Cultured Skin)
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ODT
Class f
Tissue Adhesive, Aortic Aneurysmorrhaphy
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OEE
Class 3
Diagnostic Low Electric Field
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OGO
Class 3
Intraocular Pressure Lowering Implant
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OIR
Class 3
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
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OJE
Class f
Right Ventricular Bypass (Assist) Device
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OJI
Class N
Burn Kit With Drug
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OJN
Class 3
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
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OJO
Class N
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
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OJX
Class 3
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
View devices →
OJZ
Class f
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde
View devices →
OKD
Class f
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion
View devices →
OKN
Class 3
Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy
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OLM
Class f
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
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OLQ
Class 3
Cross-Sectional Mammographic Xray System
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OLS
Class U
Oral Wound Dressing W/Drug And/Or Biologic
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OME
Class 3
Extracorporeal Shock Wave Treatment
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OMX
Class f
High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
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ONU
Class 3
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
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OOB
Class 3
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
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OOY
Class 3
Bronchial Thermoplasty System
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OPR
Class 3
Intrasaccular Flow Disruption Device
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OQS
Class N
Laboratory Developed Test
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ORL
Class 3
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
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OSR
Class 3
Pacemaker/Icd/Crt Non-Implanted Components
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OTE
Class 3
Digital Breast Tomosynthesis
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OTL
Class 3
Femtosecond Laser System For Refractive Correction
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OTQ
Class N
Research Use Only/Hematology Devices
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OTR
Class N
Research Use Only/Immunology Devices
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OTT
Class N
Research Use Only/Microbiology
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OTU
Class N
Research Use Only/Pathology
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OTV
Class N
Research Use Only/Clinical Chemistry Devices
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OTW
Class N
Research Use Only/Clinical Toxicology
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OUT
Class 3
Intracranial Aneurysm Flow Diverter
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OUU
Class f
Polymeric Neurovascular Embolization
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OVC
Class N
Headframe
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OVG
Class f
Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
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OVL
Class f
Hemodialyzer, High Cut-Off
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OVO
Class 3
Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
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OVX
Class N
Water Immersion Labor Pool
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OWD
Class 3
Somatic Gene Mutation Detection System
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OWO
Class 3
Drug-Eluting Sinus Stent
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OXR
Class N
5-Fluorouracil Assay
View devices →
OXW
Class N
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
View devices →
OYA
Class 3
P2psa
View devices →
OYB
Class 3
Kit, Rna Detection, Human Papillomavirus
View devices →
OYC
Class 3
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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OYF
Class 3
Aspiration Therapy System
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OYM
Class 3
Prostrate Cancer Genes Nucleic Acid Amplification Test System
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OYR
Class N
Filler, Bone Void, Recombinant Platelet-Derived Growth Factor
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OYY
Class N
Leukemia Translocation Panel Multiplex Test
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OZD
Class 3
Temporary Non-Roller Type Left Heart Support Blood Pump
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OZG
Class 3
Transcatheter Septal Occluder (Atrial)
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OZH
Class 3
Transcatheter Septal Occluder (Ventricular)
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OZJ
Class N
Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
View devices →
OZO
Class 3
Automated Insulin Dosing , Threshold Suspend
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OZP
Class 3
Automated Insulin Dosing Device System, Single Hormonal Control
View devices →
OZQ
Class 3
Automated Insulin Dosing Device System, Bihormonal Control
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PAA
Class 3
Automated Breast Ultrasound
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PAN
Class N
Braf Mutation Kit
View devices →
PAP
Class f
Aortic Heart Valve, More Than Minimally Manipulated Allograft
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PAQ
Class N
Test, Nr2 Antibody
View devices →
PAR
Class f
Test, Volatile Organic Compounds Breath Analysis
View devices →
PAS
Class f
Rf/Microwave Hyperthermia System, Cancer Treatment
View devices →
PAT
Class f
Bladder System
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PAX
Class f
Surgical Kit
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PAZ
Class f
Electrical Stimulation Bladder System
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PBA
Class f
Ecarin Clotting Time
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PBN
Class f
Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
View devices →
PBU
Class N
Bone Void Filler, Syringe
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PCQ
Class N
Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)
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PCW
Class N
Implantable Pulse Generator, Programmer And Battery Charger
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PCX
Class N
Artificial Chordae Tendinae Delivery System
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PCY
Class N
Investigational Use Only - Microbiology
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PCZ
Class N
Investigational Use Only - Immunology
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PDA
Class N
Investigational Use Only - Clinical Chemistry
View devices →
PDB
Class N
Investigational Use Only - Clinical Toxicology
View devices →
PDC
Class N
Investigational Use Only - Hematology
View devices →
PDD
Class N
Investigational Use Only - Pathology
View devices →
PDI
Class f
Beta 2-Microglobulin Apheresis Column
View devices →
PDR
Class 3
Computer-Assisted Personalized Sedation System
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PEJ
Class 3
Salivary Estriol Test
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PEP
Class 3
Molecular Erythrocyte Typing Test
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PFC
Class 3
Cultured Human Cell Skin Dressing
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PFE
Class N
Gastrointestinal Liner System
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PFM
Class N
Hemibridge System
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PFN
Class 3
Implanted Brain Stimulator For Epilepsy
View devices →
PFU
Class N
Tissue Processing Kit
View devices →
PFV
Class 3
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
View devices →
PFZ
Class 3
Ophthalmic Sealant
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PGE
Class 3
Gastric Emptying Breath Test
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PGO
Class N
Anti-Stick Glass Syringe
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PGQ
Class 3
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
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PHK
Class N
Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
View devices →
PHO
Class 3
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
View devices →
PHP
Class 3
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
View devices →
PIK
Class N
Metabolic Neuromodulation System
View devices →
PIL
Class N
Test For Periprosthetic Joint Infection
View devices →
PIM
Class 3
Neuromodulator For Obesity
View devices →
PIX
Class N
Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
View devices →
PIZ
Class 3
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
View devices →
PJF
Class 3
Illuminator System For Blood Products
View devices →
PJG
Class 3
Cancer-Related Germline Gene Mutation Detection System
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PJQ
Class 3
Agent, Occluding, Vascular, Permanent
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PJS
Class 3
Stimulator, Electrical, Implanted, For Essential Tremor
View devices →
PJY
Class 3
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
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PKF
Class N
D And C Tray
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PKJ
Class N
Crown And Bridge Material, Resin Based
View devices →
PKK
Class N
Stent Delivery System
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PKM
Class N
Chemiluminescent Immunoassay System
View devices →
PKW
Class 3
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
View devices →
PKY
Class 3
Implant, Dermal, For Aesthetic Use In The Hands
View devices →
PLS
Class 3
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
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PMH
Class f
Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)
View devices →
PMI
Class 3
Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement
View devices →
PMP
Class 3
Dorsal Root Ganglion Stimulator For Pain Relief
View devices →
PNC
Class N
Catheter Introducer
View devices →
PNF
Class 3
Aortic Stent
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PNW
Class 3
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
View devices →
PNY
Class 3
Absorbable Coronary Drug-Eluting Stent
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POA
Class N
Reagents, Zika Virus Nucleic Acid
View devices →
POG
Class N
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
View devices →
POH
Class 3
Mr-Guided Focused Ultrasound System
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POI
Class N
Lung Tissue Sealant For Lung Volume Reduction
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POT
Class N
Lockbox (Export Only)
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PQF
Class 3
Sensor, Glucose, Invasive, Non-Adjunctive
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PQP
Class 3
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
View devices →
PRC
Class 3
Drug-Coated Peripheral Transluminal Angioplasty Catheter
View devices →
PRF
Class N
Docetaxel / Paclitaxel Assay
View devices →
PRL
Class 3
Iliac Covered Stent, Arterial
View devices →
PSR
Class 3
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
View devices →
PSS
Class N
Minoxidil Sulfotransferase Or Isoenzymes Test System
View devices →
PUV
Class 3
Lymph Node Location System During Sentinel Biopsy Procedure
View devices →
PWC
Class N
General Wellness Product
View devices →
PWG
Class N
Spinal Fixation System
View devices →
PYS
Class N
Zika Virus Serological Reagents (Emergency Use)
View devices →
PZC
Class N
Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
View devices →
PZE
Class 3
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
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PZN
Class N
Placental Growth Factor Test
View devices →
PZT
Class N
Peripheral Blood Processing Device For Osteoarthritis
View devices →
PZU
Class N
Bone Marrow Processing Device For Clinical Use
View devices →
PZV
Class N
Peripheral Blood Processing Device For Clinical Use
View devices →
QAN
Class 3
Stent, Iliac Vein
View devices →
QBA
Class 3
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
View devices →
QBB
Class 3
Placental Alpha Microglobulin-1 Immunoassay
View devices →
QBG
Class N
Assay, Oral Direct Thrombin Inhibitor
View devices →
QBI
Class 3
Acute Coronary Syndrome Event Detector
View devices →
QBT
Class 3
Artificial Iris
View devices →
QCA
Class 3
Intracranial Coil-Assist Stent
View devices →
QCD
Class 3
Continuous Glucose Monitor, Implanted, Adjunctive Use
View devices →
QCG
Class N
Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions
View devices →
QCT
Class 3
Scaffold, Dissection Repair
View devices →
QCZ
Class 3
Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator
View devices →
QES
Class 3
Reherniation Reduction Device
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QFI
Class N
Synthetic Next-Generation Sequencing Quality Control And Filler Material
View devices →
QFK
Class N
Tumor Gene Profiling Test
View devices →
QFV
Class 3
Implantable Pulse Generator
View devices →
QGP
Class N
Posterior Ratcheting Rod System
View devices →
QGZ
Class 3
Electrical Tumor Treatment Fields
View devices →
QHJ
Class 3
Sensor, Glucose, Implanted, Non-Adjunctive Use
View devices →
QHP
Class N
Vertebral Body Tethering System
View devices →
QHV
Class N
Multiple Osteoarticular Pathogen Antigen Kit
View devices →
QIK
Class 3
Organ Care System (Ocs) Heart System
View devices →
QIM
Class N
Bartonella Spp. Serological Reagents
View devices →
QIN
Class N
Babesia Spp. Serological Reagents
View devices →
QIO
Class N
Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
View devices →
QIP
Class N
Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
View devices →
QIQ
Class N
Orientia Spp. (Scrub Typhus) Serological Reagents
View devices →
QIT
Class 3
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
View devices →
QIX
Class N
System, Transdermal Delivery, Cder Or Cber Led
View devices →
QIY
Class N
Nasal Spray, Systemic Delivery, Cder Or Cber Led
View devices →
QIZ
Class N
Material, Implantable For Controlled Release, Cder Or Cber Led
View devices →
QJA
Class 3
Tympanostomy Tube Delivery Product With Drug
View devices →
QJR
Class N
Reagents, 2019-Novel Coronavirus Nucleic Acid
View devices →
QJX
Class 3
Caries Detection Product With Drug Or Biologic
View devices →
QKJ
Class 3
Stent, Central Venous
View devices →
QKO
Class N
Reagent, Coronavirus Serological
View devices →
QKP
Class N
Coronavirus Antigen Detection Test System.
View devices →
QKR
Class N
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
View devices →
QKS
Class N
Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
View devices →
QKU
Class N
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)
View devices →
QKY
Class N
Decontamination Systems For N95 Respirators
View devices →
QLC
Class N
Interleukin 6
View devices →
QLD
Class N
Protective Barrier Enclosure
View devices →
QLE
Class N
Protective Barrier Enclosure With Negative Pressure
View devices →
QLH
Class N
System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led
View devices →
QLI
Class N
Vaporizer, Cder Or Cber Led
View devices →
QLJ
Class N
Patient Monitor With Independent Remote Display And Operation
View devices →
QLK
Class 3
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
View devices →
QLL
Class N
Left Ventricular Ejection Fraction Screening Tool
View devices →
QLM
Class N
Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
View devices →
QLN
Class N
Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
View devices →
QLO
Class N
Immunoadsorption Column For Emergency Use
View devices →
QLT
Class N
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
View devices →
QLW
Class N
Covid-19 Test Home Collection Kit Devices
View devices →
QMF
Class N
Mask, Surgical, Eua Authorized
View devices →
QMG
Class 3
Shockwave Intravascular Lithotripsy System
View devices →
QMN
Class N
Covid-19 Multi-Analyte Antigen Device
View devices →
QNB
Class f
Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein
View devices →
QNK
Class 3
Optoacoustic Imaging System
View devices →
QNN
Class f
Prosthesis, Total Talus Replacement, Metal
View devices →
QNY
Class N
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
View devices →
QNZ
Class N
Powered Communication System For Emergency Use
View devices →
QOA
Class N
Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
View devices →
QOC
Class N
Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
View devices →
QOD
Class N
Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure
View devices →
QOJ
Class N
Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)
View devices →
QOO
Class N
Ventilator Tubing And Accessories
View devices →
QOP
Class N
Respiratory Humidifier For Emergency Use
View devices →
QOQ
Class N
Non-Continuous Ventilator For Emergency Use
View devices →
QOR
Class N
Continuous Ventilator, Minimal Ventilatory Support
View devices →
QOS
Class N
Continuous Ventilator
View devices →
QOT
Class N
Emergency Ventilator
View devices →
QOU
Class N
Emergency Resuscitator
View devices →
QOV
Class N
Critical Care Ventilator
View devices →
QOW
Class N
Ventilatory Assistance Helmet
View devices →
QOX
Class N
Multi-Patient Circuit Connector
View devices →
QOZ
Class N
Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy
View devices →
QPK
Class N
Eua Faceshields
View devices →
QPR
Class N
Neurological Stimulation For Emergency Use
View devices →
QPT
Class 3
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
View devices →
QPW
Class N
Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube
View devices →
QPY
Class 3
Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
View devices →
QQF
Class N
Skin Microneedling Manual/Automated Device (Export Only)
View devices →
QQK
Class 3
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
View devices →
QQT
Class 3
Immunohistochemistry Assay, Antibody, Ki-67
View devices →
QRB
Class 3
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
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QRF
Class 3
Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
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QRH
Class 3
Catheter, Balloon, Urethral, Drug-Coated
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QRU
Class 3
Implant, Resorbable, For Articular Osteochondral Repair
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QSF
Class 3
Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
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QSH
Class N
Coronavirus Marker Detection
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QSK
Class 3
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
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QSS
Class 3
Hiv Self-Tests
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QTA
Class N
Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
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QTB
Class 3
Nitric Oxide Generator And Delivery System
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QTK
Class f
Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device
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QTP
Class N
Reagents, Monkeypox Virus Nucleic Acid.
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QTQ
Class N
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
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QTU
Class N
Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
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QVG
Class 3
Embolization Agent, Vascular
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QVW
Class N
Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
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QWC
Class 3
Pulmonary Stent
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QWK
Class 3
Prosthesis, Posterior Spinal Elements
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QWM
Class 3
Stent Graft, Bypass, Superficial Femoral Artery
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QWN
Class 3
Stent Graft, Infrapopliteal, Venous Arterialization
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QWQ
Class 3
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
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QWY
Class 3
Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator
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QXB
Class 3
Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
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QYI
Class 3
Ablation Catheter, Renal Denervation
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QYQ
Class f
Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal
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QZH
Class 3
Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
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QZI
Class 3
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
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QZK
Class 3
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
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QZT
Class N
Gowns And Other Apparel
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QZV
Class 3
Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
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RAA
Class N
Laser Products (Pre-Standard)
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RAC
Class N
Nondestructive Tests
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RAD
Class N
Gauging
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RAE
Class N
Ranging
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RAF
Class N
Cleaner
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RAG
Class N
Welder
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RAH
Class N
Jewelry Cleaner
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RAI
Class N
Motion Detector/Occupancy
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RAJ
Class N
Security System
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RAK
Class N
Pest Repeller
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RAL
Class N
Massager
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RAM
Class N
Humidifier
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RAN
Class N
Auto Focus Camera
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RAO
Class N
Intrusion Alarm/Security
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RAP
Class N
Scientific Use Ultrasound Products
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RAQ
Class N
Audio System/Radio
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RAR
Class N
Telephone Ringer
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RAS
Class N
Veterinary Diagnostic Ultrasonic Products
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RAT
Class N
Veterinary Therapy Ultrasonic Products
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RAU
Class N
Night Vision Scope
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RAV
Class N
High Voltage Tubes
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RAW
Class N
Cathode Ray Tubes
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RAX
Class N
High Voltage Vacuum Switches
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RAY
Class N
Oscilloscope (Exempted)
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RAZ
Class N
Television Receiver, Medical Imaging, Color
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RBA
Class N
Television Receiver, Medical Imaging, Monochrome
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RBB
Class N
Television Receiver, General Purpose, Color
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RBC
Class N
Television Receiver, General Purpose, Monochrome
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RBD
Class N
Video Monitor, Medical Imaging, Color
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RBE
Class N
Video Monitor, General Purpose, Color
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RBF
Class N
Video Monitor, Medical Imaging, Monochrome
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RBG
Class N
Video Monitor, General Purpose, Monochrome
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RBH
Class N
Projector
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RBI
Class N
Tv View Finder (Exempted)
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RBJ
Class N
Cold-Cathode Gas Discharge Tubes
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RBK
Class N
Betatron, Non-Medical
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RBL
Class N
Cyclotron,Non-Medical
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RBM
Class N
Microtron, Non-Medical
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RBN
Class N
Synchrotron, Non-Medical
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RBO
Class N
Sterilizers, Non-Medical
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RBP
Class N
Industrial Accelerator
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RBQ
Class N
Security Accelerator
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RBR
Class N
Diagnostic X-Ray Equipment (Noncertified)
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RBS
Class N
Industrial X-Ray
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RBT
Class N
Bottle Fill Checker
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RBU
Class N
X-Ray Thickness Gauge
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RBV
Class N
Security X-Ray System, Open Beam, Small
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RBW
Class N
X-Ray Diffraction
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RBX
Class N
X-Ray Spectroscopy
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RBY
Class N
X-Ray Fluorescence
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RBZ
Class N
X-Ray Controls ? Combination
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RCA
Class N
X-Ray Controls - Fluoroscopic
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RCB
Class N
X-Ray Controls - Radiographic
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RCD
Class N
X-Ray Image Receptor
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RCE
Class N
Cabinet X-Ray, Industrial
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RCF
Class N
Cabinet X-Ray Explosive Detection Systems
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RCG
Class N
Cabinet X-Ray, Security (Includes Baggage X-Ray)
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RCH
Class N
Cabinet X-Ray, Vehicle And Cargo
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RCI
Class N
Cephalometric Devices
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RCJ
Class N
Veterinary Diagnostic X-Ray System
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RCK
Class N
Veterinary X-Ray Therapy System
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RCL
Class N
Ion Beam Implanter
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RCM
Class N
Microscope (Electron Beam), Non-Medical
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RCN
Class N
Personnel Security Backscatter X-Ray System
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RCO
Class N
Personnel Security Transmission X-Ray System
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RCP
Class N
Vehicle And Cargo X-Ray System, Mobile
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RCQ
Class N
Vehicle And Cargo X-Ray System, Stationary
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RCR
Class N
Microwave Oven, Consumer
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RCS
Class N
Microwave Oven, Commercial
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RCT
Class N
Tunnel/Conveyor
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RCU
Class N
Vending Machine
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RCV
Class N
Food Processing
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RCW
Class N
Materials Processing
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RCX
Class N
Clothes Dryer
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RCY
Class N
Medical Waste/Sterilizer
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RCZ
Class N
Materials Processing, Laboratories
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RDA
Class N
Dielectric Heaters, Induction Heaters, Rf Sealers
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RDB
Class N
Electric Blanket
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RDC
Class N
Shavers
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RDD
Class N
Hair Dryer
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RDE
Class N
Sewing Machine
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RDF
Class N
Motor
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RDG
Class N
Veterinary, Microwave Medical Products
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RDH
Class N
Air Traffic Control
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RDI
Class N
Police Radar
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RDJ
Class N
Rf Identification
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RDK
Class N
Electronic Article Surveillance (Eas)
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RDL
Class N
Stun Gun
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RDM
Class N
Anti-Theft Detector (Non-Eas)
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RDN
Class N
Walkie-Talkie
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RDO
Class N
Microwave Lan
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RDP
Class N
Wireless (Cordless) Telephone
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RDQ
Class N
Cb Amateur Radio
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RDS
Class N
Weather Doppler
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RDT
Class N
Rf-Excited Lighting
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RDU
Class N
Pest Controller
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RDV
Class N
Automotive Accessory, Automobile Or Transport Vehicle
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RDW
Class N
General Purpose Laser Products
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RDX
Class N
Mercury Vapor Lamp
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RDY
Class N
Metal Halide Lamp
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RDZ
Class N
Low-Power Laser Light Show Projector
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REA
Class N
High-Power Laser Light Show Projector
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REB
Class N
High-Power Laser Light Show
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REC
Class N
Laser Video Projector
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RED
Class N
Laser Advertising Display System
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REE
Class N
Laser Visual Display - Display Retinal Image, Non-Medical
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REI
Class N
Laser Science Education Products
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REJ
Class N
Laser Children'S Toy/Novelty Product
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REK
Class N
Research Laser
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REL
Class N
Guide-Star Laser System
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REM
Class N
Spectroscopy Instrument
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REN
Class N
Particle-Size Measuring Instrument
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REO
Class N
Analytical Measuring And Detection Laser Product
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REP
Class N
Surveying Laser Product
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REQ
Class N
Laser Rangefinders, Time-Of-Flight Speed Measurement Products
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RER
Class N
Alignment Laser Product
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RES
Class N
Laser Pointer
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RET
Class N
Laser Target Designator
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REU
Class N
Laser Aiming Product, Visible
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REV
Class N
Laser Aiming Product, Non-Visible
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REW
Class N
Ir Laser Illuminator With Alignment Aid/Night Vision System
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REX
Class N
Ir Laser Illuminator Only/Night Vision System
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REY
Class N
Collision-Avoidance Laser System
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REZ
Class N
Laser Traffic Signal
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RFA
Class N
Laser Automotive Lighting & Signals
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RFB
Class N
Ir Laser Intrusion Detection/Security System
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RFC
Class N
Laser Distance, Detection, Ranging (Lidar)
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RFD
Class N
Laser Weapon (Military Or Police)
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RFE
Class N
Laser Cutter
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RFF
Class N
Laser Welder
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RFG
Class N
Microelectronic Mask Or Chip Processing, Checking, And/Or Repair
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RFI
Class N
Print Industry Plate Maker
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RFJ
Class N
Process Control
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RFK
Class N
Laser Vision
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RFL
Class N
Laser Micrometer
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RFM
Class N
Laser-Based Material Positioning System
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RFN
Class N
Fiber Optic Communication And Data Transfer
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RFO
Class N
Ir Free-Space Data Transmit/Control Laser
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RFP
Class N
Remote Controller
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RFQ
Class N
Interferometric Position Measuring Product
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RFR
Class N
Product Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control Product
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RFS
Class N
Reprographics
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RFT
Class N
Laser Printer
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RFU
Class N
Laser Fax Machine
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RFV
Class N
Cd, Cd-Rom Player
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RFW
Class N
Dvd, Dvd-Rom, Bluray, Hd Player
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RFX
Class N
Cd-R, Cd-Rw Recorder
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RFY
Class N
Dvd, Bluray, Or Hd Recorder
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RFZ
Class N
Upc Scanner Reader (Bar Code Reader)
View devices →
RGA
Class N
Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product
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RGB
Class N
Veterinary Laser
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RGD
Class N
Counterfeit Detection
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RGE
Class N
Scientific Crystallography
View devices →
RGF
Class N
Forensics
View devices →
RGG
Class N
Forensics Laser
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RGH
Class N
Toilet Seat Sanitizer
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RGI
Class N
Hand Washing Sanitizer
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RGJ
Class N
Countertop Sanitizer
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RGK
Class N
Towel Cleaner
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RGM
Class N
Photochemical Curing And Adhesive
View devices →
RGN
Class N
Photochemical Curing And Adhesive Laser
View devices →
RGO
Class N
Uv Curing
View devices →
RGP
Class N
Black Light
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RGQ
Class N
Cosmetology Uv Lamp
View devices →
RGS
Class N
Water Purifier
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RGT
Class N
Spectroscopy, Ultraviolet Fluorescence
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RGU
Class N
X-Ray Field Indicator Light Field (Non-Laser)
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RGV
Class N
Veterinary Optical Product
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RGW
Class N
Uv/Ir Research
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RGX
Class N
Fluorescent Lamp
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RGY
Class N
Ir Intrusion Detector
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RGZ
Class N
Ir Security
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RHA
Class N
Ir Data Transmit/Control
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RHB
Class N
Tungsten Halogen Lamp
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RHC
Class N
High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)
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RHD
Class N
Ir Remote Controller
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RHF
Class N
Digital Display Monitor
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RHG
Class N
Light, Spectrum, Broad (Non-Medical)
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RHH
Class N
Led Lamps Emitting Visible Light Intended To Be Used For Illumination Purposes
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RHI
Class N
Mercury Vapor Lamp, Not Self-Extinguishing, R-Type
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RHJ
Class N
Television, Less Than 25kv And Less Than 0.1 Mr/Hr
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RHK
Class N
Laser Marker Or Engraver, Industrial Or Commercial
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RHL
Class N
Laser Therapy Product
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RHM
Class N
Image Digitizer
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RHN
Class N
Fiber Optic Instrument For Testing Optical Fibers
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RHO
Class N
Sound Amplification Product
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RHP
Class N
Uv Lamp, Germicidal
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RHQ
Class N
Hologram Displaying Or Creating Laser Product.
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RHR
Class N
Laser Holographic System For Experiments, Research, Or Prototype Development
View devices →
RHS
Class N
Laser Holographic System
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RHT
Class N
Laser Mouse, Trackball, Or Similar
View devices →
RHU
Class N
Led For Signaling/Tracking/Triggering
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RHV
Class N
Metal Deposition Laser Product
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RHW
Class N
Uv Lamp For Home Or Business Uses
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RHX
Class N
Sodium Vapor Lamp
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RHY
Class N
Laser Sensing System
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RHZ
Class N
3d Laser Scanning System
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RIA
Class N
High Intensity Lamp
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RIB
Class N
Microscopy Laser Instrument Or Accessory Products
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RIC
Class N
Ultrasonic Cutter
View devices →
RID
Class N
Liquid Crystal Display (Lcd)
View devices →
RIE
Class N
Visible Laser Illuminator
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RIF
Class N
Smart Meter
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RIG
Class N
Laser Illuminated Projector
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RIH
Class N
Metal Halide Lamp, Other
View devices →
RII
Class N
Scientific Optical Instrument, Noncoherent
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RIJ
Class N
Automotive Radar
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RIK
Class N
Television Or Monitor, Non-Crt, Non-Medical, Video Display
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RIL
Class N
Laser Ignition Tool
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RIM
Class N
Laser Marker, Cutter, Or Engraver, Tabletop, Consumer
View devices →
RIN
Class N
Laser Illuminated Lighting Instrument
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RIO
Class N
Led Toys And Entertainment Products
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RIP
Class N
Led Diodes Sold As Components To Be Installed In Finished Electronic Products
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RIQ
Class N
Low Emission Leds As Indicators Or Decorations
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SAD
Class N
Japanese Encephalitis Virus Immunological/Serology Test
View devices →
SAW
Class 3
Fluorescence Imaging For Breast Cancer Detection
View devices →
SAZ
Class 3
Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb
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SBB
Class 3
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
View devices →
SCE
Class N
Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
View devices →
SCF
Class N
Ldt, Unmet Need Within An Integrated Healthcare System
View devices →
SCG
Class N
Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule
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SCH
Class N
Ldt, Approved By Nys Clep
View devices →
SCI
Class N
Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
View devices →
SCJ
Class N
Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
View devices →
SCK
Class N
Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
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SDA
Class 3
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
View devices →
SDK
Class 3
Transdermal Test For Assessment Of Glomerular Filtration Rate
View devices →
SDL
Class 3
Transvenous Temporary Phrenic Nerve Stimulator
View devices →
SDM
Class U
Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
View devices →
SDN
Class U
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
View devices →
SDQ
Class 3
Alfapump System
View devices →
SDZ
Class 3
Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions
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SEG
Class 3
Leadless Cardiac Resynchronization Therapy (Crt)
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SEQ
Class 3
Covered Stent Vascular Connector, Hemodialysis Access Circuit
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SFA
Class 3
Prosthesis, Finger, Semi-Constrained, Metal/Polymer
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SFI
Class 3
Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
View devices →
SFJ
Class 3
Vagus Nerve Stimulator For Rheumatoid Arthritis
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SFL
Class 3
Nucleic Acid Based Assay, Microsatellite Instability
View devices →
SGD
Class f
Kit D816v Mutation Detection System
View devices →
SGF
Class f
Dural Arteriovenous Fistula Liquid Embolic
View devices →
SGK
Class 3
Prosthesis, Spinous Process Tension Band Implant
View devices →
SGS
Class 3
Deep Brain Stimulation For The Treatment Of Dystonia
View devices →
SGU
Class 3
Neurovascular Liquid Embolic Agent
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SHC
Class 3
Low Electric Field Generator For Pancreatic Cancer Treatment
View devices →
SHH
Class 3
Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
View devices →
SIB
Class N
Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic
View devices →
SIC
Class N
Tempo Pilot Ckm: Cardio-Kidney-Metabolic
View devices →
SID
Class N
Tempo Pilot Msk: Musculoskeletal
View devices →
SIE
Class N
Tempo Pilot Bh: Behavioral Health
View devices →
SIL
Class U
Wound Dressings Containing Oxygen
View devices →
SIO
Class 3
Test For Esophageal Varices
View devices →No matching product codes.
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