General, Plastic Surgery Device Classification Codes

GEX Class 2

Powered Laser Surgical Instrument

Clearances 2779

Regulation 21 CFR 878.4810

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GEI Class 2

Electrosurgical, Cutting & Coagulation & Accessories

Clearances 2223

Regulation 21 CFR 878.4400

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FXX Class 2

Mask, Surgical

Clearances 601

Regulation 21 CFR 878.4040

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KGO Class 1

Surgeon'S Gloves

Clearances 541

Regulation 21 CFR 878.4460

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KKX Class 2

Drape, Surgical, Antimicrobial

Clearances 442

Regulation 21 CFR 878.4370

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FTL Class 2

Mesh, Surgical, Polymeric

Clearances 313

Regulation 21 CFR 878.3300

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FYA Class 2

Gown, Surgical

Clearances 290

Regulation 21 CFR 878.4040

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FTC Class 2

Light, Ultraviolet, Dermatological

Clearances 267

Regulation 21 CFR 878.4630

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GDW Class 2

Staple, Implantable

Clearances 261

Regulation 21 CFR 878.4750

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GEH Class 2

Unit, Cryosurgical, Accessories

Clearances 247

Regulation 21 CFR 878.4350

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OMP Class 2

Negative Pressure Wound Therapy Powered Suction Pump

Clearances 185

Regulation 21 CFR 878.4780

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FZP Class 2

Clip, Implantable

Clearances 167

Regulation 21 CFR 878.4300

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GAT Class 2

Suture, Nonabsorbable, Synthetic, Polyethylene

Clearances 165

Regulation 21 CFR 878.5000

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OHT Class 2

Light Based Over-The-Counter Hair Removal

Clearances 159

Regulation 21 CFR 878.4810

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BTA Class 2

Pump, Portable, Aspiration (Manual Or Powered)

Clearances 156

Regulation 21 CFR 878.4780

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OHS Class 2

Light Based Over The Counter Wrinkle Reduction

Clearances 154

Regulation 21 CFR 878.4810

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FTM Class 2

Mesh, Surgical

Clearances 152

Regulation 21 CFR 878.3300

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GAM Class 2

Suture, Absorbable, Synthetic, Polyglycolic Acid

Clearances 134

Regulation 21 CFR 878.4493

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FMK Class 2

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Clearances 111

Regulation 21 CFR 878.4850

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GDY Class 1

Gauze/Sponge, Internal, X-Ray Detectable

Clearances 111

Regulation 21 CFR 878.4450

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LRO Class 2

General Surgery Tray

Clearances 110

Regulation 21 CFR 878.4370

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NAD Class 1

Dressing, Wound, Occlusive

Clearances 108

Regulation 21 CFR 878.4020

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GAA Class 1

Needle, Aspiration And Injection, Disposable

Clearances 107

Regulation 21 CFR 878.4800

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GEN Class 1

Forceps, General & Plastic Surgery

Clearances 104

Regulation 21 CFR 878.4800

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GAD Class 1

Retractor

Clearances 100

Regulation 21 CFR 878.4800

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NEU Class 2

Marker, Radiographic, Implantable

Clearances 100

Regulation 21 CFR 878.4300

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GCY Class 1

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Clearances 96

Regulation 21 CFR 878.4680

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NAB Class 1

Gauze / Sponge,Nonresorbable For External Use

Clearances 88

Regulation 21 CFR 878.4014

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MDA Class 1

Elastomer, Silicone, For Scar Management

Clearances 81

Regulation 21 CFR 878.4025

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GAW Class 2

Suture, Nonabsorbable, Synthetic, Polypropylene

Clearances 80

Regulation 21 CFR 878.5010

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FSM Class 1

Tray, Surgical, Instrument

Clearances 76

Regulation 21 CFR 878.4800

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GBX Class 1

Catheter, Irrigation

Clearances 76

Regulation 21 CFR 878.4200

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HWE Class 1

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Clearances 75

Regulation 21 CFR 878.4820

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FYD Class 2

Apparatus, Exhaust, Surgical

Clearances 73

Regulation 21 CFR 878.5070

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HTD Class 1

Forceps

Clearances 73

Regulation 21 CFR 878.4800

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JCX Class 2

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Clearances 73

Regulation 21 CFR 878.4780

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PBX Class 2

Massager, Vacuum, Radio Frequency Induced Heat

Clearances 73

Regulation 21 CFR 878.4400

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LEJ Class 2

Booth, Sun Tan

Clearances 72

Regulation 21 CFR 878.4635

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FYC Class 2

Gown, Isolation, Surgical

Clearances 68

Regulation 21 CFR 878.4040

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FSY Class 2

Light, Surgical, Ceiling Mounted

Clearances 67

Regulation 21 CFR 878.4580

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KDC Class 1

Instrument, Surgical, Disposable

Clearances 67

Regulation 21 CFR 878.4800

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NEY Class 2

System, Ablation, Microwave And Accessories

Clearances 65

Regulation 21 CFR 878.4400

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FWP Class 2

Prosthesis, Chin, Internal

Clearances 64

Regulation 21 CFR 878.3550

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NEW Class 2

Suture, Surgical, Absorbable, Polydioxanone

Clearances 64

Regulation 21 CFR 878.4840

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ONF Class 2

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Clearances 64

Regulation 21 CFR 878.4810

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OTN Class 2

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Clearances 64

Regulation 21 CFR 878.3300

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KDD Class 1

Kit, Surgical Instrument, Disposable

Clearances 62

Regulation 21 CFR 878.4800

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FWZ Class 1

Operating Room Accessories Table Tray

Clearances 61

Regulation 21 CFR 878.4950

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ESW Class 2

Prosthesis, Esophageal

Clearances 60

Regulation 21 CFR 878.3610

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LNK Class 2

Laser For Gastro-Urology Use

Clearances 60

Regulation 21 CFR 878.4810

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QPB Class 2

System, Suction, Lipoplasty For Removal

Clearances 58

Regulation 21 CFR 878.5040

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GAR Class 2

Suture, Nonabsorbable, Synthetic, Polyamide

Clearances 56

Regulation 21 CFR 878.5020

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HSZ Class 1

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Clearances 56

Regulation 21 CFR 878.4820

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LYU Class 1

Accessory, Surgical Apparel

Clearances 56

Regulation 21 CFR 878.4040

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JDK Class 2

Prosthesis, Hip, Cement Restrictor

Clearances 54

Regulation 21 CFR 878.3300

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OCL Class 2

Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Clearances 53

Regulation 21 CFR 878.4400

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FZT Class 1

Cutter, Surgical

Clearances 52

Regulation 21 CFR 878.4800

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GDM Class 1

Needle, Aspiration And Injection, Reusable

Clearances 48

Regulation 21 CFR 878.4800

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GES Class 1

Blade, Scalpel

Clearances 48

Regulation 21 CFR 878.4800

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OLP Class 2

Over-The-Counter Powered Light Based Laser For Acne

Clearances 45

Regulation 21 CFR 878.4810

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FST Class 2

Light, Surgical, Fiberoptic

Clearances 44

Regulation 21 CFR 878.4580

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MDM Class 1

Instrument, Manual, Surgical, General Use

Clearances 44

Regulation 21 CFR 878.4800

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KCW Class 1

Epilator, High Frequency, Needle-Type

Clearances 43

Regulation 21 CFR 878.5350

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FZE Class 2

Prosthesis, Nose, Internal

Clearances 42

Regulation 21 CFR 878.3680

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JCT Class 2

Prosthesis, Tracheal, Expandable

Clearances 42

Regulation 21 CFR 878.3720

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GAP Class 2

Suture, Nonabsorbable, Silk

Clearances 41

Regulation 21 CFR 878.5030

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GEY Class 1

Motor, Surgical Instrument, Ac-Powered

Clearances 41

Regulation 21 CFR 878.4820

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LZK Class 2

Implant, Malar

Clearances 40

Regulation 21 CFR 878.3550

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GEC Class 1

Brush, Scrub, Operating-Room

Clearances 37

Regulation 21 CFR 878.4800

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LZN Class 2

Cement Obturator

Clearances 37

Regulation 21 CFR 878.3300

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FXP Class 1

Cover, Shoe, Operating-Room

Clearances 36

Regulation 21 CFR 878.4040

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GEA Class 1

Cannula, Surgical, General & Plastic Surgery

Clearances 36

Regulation 21 CFR 878.4800

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JOS Class 2

Electrode, Electrosurgical

Clearances 36

Regulation 21 CFR 878.4400

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FQO Class 1

Table, Operating-Room, Ac-Powered

Clearances 35

Regulation 21 CFR 878.4960

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KCY Class 1

Tourniquet, Pneumatic

Clearances 34

Regulation 21 CFR 878.5910

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MSH Class 2

Respirator, Surgical

Clearances 34

Regulation 21 CFR 878.4040

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NUJ Class 2

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Clearances 34

Regulation 21 CFR 878.4400

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MUU Class 2

System, Suction, Lipoplasty

Clearances 33

Regulation 21 CFR 878.5040

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ONG Class 2

Powered Laser Surgical Instrument With MicrobeamFractional Output

Clearances 33

Regulation 21 CFR 878.4810

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FYF Class 1

Cap, Surgical

Clearances 32

Regulation 21 CFR 878.4040

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GDJ Class 1

Clamp, Surgical, General & Plastic Surgery

Clearances 32

Regulation 21 CFR 878.4800

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HAM Class 2

Apparatus, Electrosurgical

Clearances 31

Regulation 21 CFR 878.4400

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GAQ Class 2

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Clearances 30

Regulation 21 CFR 878.4495

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FTD Class 2

Lamp, Surgical

Clearances 29

Regulation 21 CFR 878.4580

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GAL Class 2

Suture, Absorbable, Natural

Clearances 29

Regulation 21 CFR 878.4830

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KGZ Class 1

Accessories, Catheter

Clearances 29

Regulation 21 CFR 878.4200

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KIJ Class 1

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Clearances 29

Regulation 21 CFR 878.4820

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NAE Class 1

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Clearances 29

Regulation 21 CFR 878.4022

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GDF Class 1

Guide, Needle, Surgical

Clearances 28

Regulation 21 CFR 878.4800

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MPN Class 2

Tissue Adhesive For The Topical Approximation Of Skin

Clearances 28

Regulation 21 CFR 878.4010

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GBS Class 1

Catheter, Ventricular, General & Plastic Surgery

Clearances 27

Regulation 21 CFR 878.4200

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GFA Class 1

Blade, Saw, General & Plastic Surgery, Surgical

Clearances 27

Regulation 21 CFR 878.4820

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HBI Class 2

Illuminator, Fiberoptic, Surgical Field

Clearances 27

Regulation 21 CFR 878.4580

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QRL Class 2

Multiple Use Blood Lancet For Single Patient Use Only

Clearances 27

Regulation 21 CFR 878.4850

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GDX Class 1

Scalpel, One-Piece

Clearances 26

Regulation 21 CFR 878.4800

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OHV Class 2

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Clearances 26

Regulation 21 CFR 878.4590

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OLI Class 2

Fat Reducing Low Level Laser

Clearances 26

Regulation 21 CFR 878.5400

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KCX Class 1

Epilator, High Frequency, Tweezer-Type

Clearances 25

Regulation 21 CFR 878.5360

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QAI Class 2

Powered Microneedle Device

Clearances 25

Regulation 21 CFR 878.4430

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GBZ Class 1

Catheter, Cholangiography

Clearances 24

Regulation 21 CFR 878.4200

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FTY Class 1

Tape, Measuring, Rulers And Calipers

Clearances 23

Regulation 21 CFR 878.4800

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FWF Class 1

Camera, Television, Endoscopic, Without Audio

Clearances 23

Regulation 21 CFR 878.4160

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FZZ Class 1

Marker, Skin

Clearances 23

Regulation 21 CFR 878.4660

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GET Class 1

Motor, Surgical Instrument, Pneumatic Powered

Clearances 23

Regulation 21 CFR 878.4820

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KPJ Class 2

Chamber, Oxygen, Topical, Extremity

Clearances 23

Regulation 21 CFR 878.5650

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FTA Class 2

Light, Surgical, Accessories

Clearances 22

Regulation 21 CFR 878.4580

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KOZ Class 1

Beads, Hydrophilic, For Wound Exudate Absorption

Clearances 22

Regulation 21 CFR 878.4018

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LRP Class 1

Tray, Surgical

Clearances 22

Regulation 21 CFR 878.4800

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EMF Class 1

Knife, Surgical

Clearances 21

Regulation 21 CFR 878.4800

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HTZ Class 1

Instrument, Cutting, Orthopedic

Clearances 21

Regulation 21 CFR 878.4800

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KKY Class 2

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Clearances 21

Regulation 21 CFR 878.3500

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BWN Class 1

Table And Attachments, Operating-Room

Clearances 20

Regulation 21 CFR 878.4950

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FSS Class 2

Light, Surgical, Floor Standing

Clearances 20

Regulation 21 CFR 878.4580

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GAX Class 1

Tourniquet, Nonpneumatic

Clearances 20

Regulation 21 CFR 878.5900

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KGS Class 1

Retention Device, Suture

Clearances 20

Regulation 21 CFR 878.4930

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NUV Class 2

Massager, Vacuum, Light Induced Heating

Clearances 20

Regulation 21 CFR 878.4810

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OTO Class 2

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Clearances 20

Regulation 21 CFR 878.3300

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PAH Class 2

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Clearances 20

Regulation 21 CFR 878.3300

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FZX Class 1

Guide, Surgical, Instrument

Clearances 19

Regulation 21 CFR 878.4800

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GDT Class 1

Staple, Removable (Skin)

Clearances 19

Regulation 21 CFR 878.4760

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KAM Class 1

Cannula, Sinus

Clearances 19

Regulation 21 CFR 878.4800

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EPT Class 1

Microscope, Surgical

Clearances 18

Regulation 21 CFR 878.4700

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GDC Class 1

Table, Operating-Room, Electrical

Clearances 18

Regulation 21 CFR 878.4960

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KQM Class 1

Camera, Surgical And Accessories

Clearances 18

Regulation 21 CFR 878.4160

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LRW Class 1

Scissors, General, Surgical

Clearances 18

Regulation 21 CFR 878.4800

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PDZ Class 2

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Clearances 18

Regulation 21 CFR 878.4810

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GAS Class 2

Suture, Nonabsorbable, Synthetic, Polyester

Clearances 17

Regulation 21 CFR 878.5000

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GBI Class 1

Material, External Aesthetic Restoration, Used With Adhesive

Clearances 17

Regulation 21 CFR 878.3800

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GBW Class 1

Catheter, Peritoneal

Clearances 17

Regulation 21 CFR 878.4200

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HMP Class 1

Pad, Eye

Clearances 17

Regulation 21 CFR 878.4440

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NVK Class 2

Laser, Dental, Soft Tissue

Clearances 17

Regulation 21 CFR 878.4810

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PKT Class 2

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Clearances 17

Regulation 21 CFR 878.5400

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QRK Class 2

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Clearances 17

Regulation 21 CFR 878.4850

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GDZ Class 1

Handle, Scalpel

Clearances 16

Regulation 21 CFR 878.4800

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GFF Class 1

Bur, Surgical, General & Plastic Surgery

Clearances 16

Regulation 21 CFR 878.4820

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MQR Class 2

Stent, Colonic, Metallic, Expandable

Clearances 16

Regulation 21 CFR 878.3610

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PEM Class 2

Dental Barriers And Sleeves

Clearances 16

Regulation 21 CFR 878.4370

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FSO Class 1

Microscope, Surgical, General & Plastic Surgery

Clearances 15

Regulation 21 CFR 878.4700

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HRQ Class 1

Hemostat

Clearances 15

Regulation 21 CFR 878.4800

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MCZ Class 1

Suture Removal Kit

Clearances 15

Regulation 21 CFR 878.4800

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MMP Class 2

Cover, Barrier, Protective

Clearances 15

Regulation 21 CFR 878.4370

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NBY Class 2

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Clearances 15

Regulation 21 CFR 878.5035

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FZS Class 1

Curette, Surgical, General Use

Clearances 14

Regulation 21 CFR 878.4800

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GDO Class 1

Applier, Surgical, Clip

Clearances 14

Regulation 21 CFR 878.4800

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HRM Class 1

Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

Clearances 14

Regulation 21 CFR 878.4700

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HXD Class 1

Clamp

Clearances 14

Regulation 21 CFR 878.4800

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JCY Class 1

Catheter, Infusion

Clearances 14

Regulation 21 CFR 878.4200

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LGX Class 1

Table, Examination, Medical, Powered

Clearances 14

Regulation 21 CFR 878.4960

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OAB Class 2

Low Energy Direct Current Thermal Ablation System

Clearances 14

Regulation 21 CFR 878.4400

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BTX Class 1

Board, Arm (With Cover), Sterile

Clearances 13

Regulation 21 CFR 878.3910

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FSE Class 1

Table, Operating-Room, Manual

Clearances 13

Regulation 21 CFR 878.4950

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JEB Class 1

Table, Surgical With Orthopedic Accessories, Manual

Clearances 13

Regulation 21 CFR 878.4950

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KCZ Class 1

Prosthesis, Breast, External, Used With Adhesive

Clearances 13

Regulation 21 CFR 878.3800

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OKO Class 2

Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Clearances 13

Regulation 21 CFR 878.4683

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OWY Class 2

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Clearances 13

Regulation 21 CFR 878.3300

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EPY Class 1

Speculum, Ent

Clearances 12

Regulation 21 CFR 878.1800

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EZX Class 2

Mesh, Surgical, Metal

Clearances 12

Regulation 21 CFR 878.3300

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FXY Class 2

Hood, Surgical

Clearances 12

Regulation 21 CFR 878.4040

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GEG Class 1

Elevator, Surgical, General & Plastic Surgery

Clearances 12

Regulation 21 CFR 878.4800

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GFD Class 1

Dermatome

Clearances 12

Regulation 21 CFR 878.4820

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KOX Class 1

Solvent, Adhesive Tape

Clearances 12

Regulation 21 CFR 878.4730

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OTM Class 2

Mesh, Surgical, For Stress Urinary Incontinence, Male

Clearances 12

Regulation 21 CFR 878.3300

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QPC Class 2

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Clearances 12

Regulation 21 CFR 878.4040

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DWO Class 1

Needle, Biopsy, Cardiovascular

Clearances 11

Regulation 21 CFR 878.4800

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GBO Class 1

Catheter, Nephrostomy, General & Plastic Surgery

Clearances 11

Regulation 21 CFR 878.4200

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KDG Class 1

Chisel (Osteotome)

Clearances 11

Regulation 21 CFR 878.4820

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OOD Class 2

Surgical Film

Clearances 11

Regulation 21 CFR 878.3300

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PAY Class 2

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Clearances 11

Regulation 21 CFR 878.4420

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QAU Class 2

Hemostatic Device For Endoscopic Gastrointestinal Use

Clearances 11

Regulation 21 CFR 878.4456

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GDG Class 1

Hook, Surgical, General & Plastic Surgery

Clearances 10

Regulation 21 CFR 878.4800

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HTC Class 1

Pliers, Surgical

Clearances 10

Regulation 21 CFR 878.4800

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JEA Class 1

Table, Surgical With Orthopedic Accessories, Ac-Powered

Clearances 10

Regulation 21 CFR 878.4960

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OOK Class 2

Dermal Cooling Pack/Vacuum/Massager

Clearances 10

Regulation 21 CFR 878.4340

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OWT Class 2

Mesh, Surgical, Absorbable, Abdominal Hernia

Clearances 10

Regulation 21 CFR 878.3300

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OWW Class 2

Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Clearances 10

Regulation 21 CFR 878.3300

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PSN Class 2

Light Based Imaging

Clearances 10

Regulation 21 CFR 878.4580

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PZX Class 2

Left Atrial Appendage Clip, Implantable

Clearances 10

Regulation 21 CFR 878.4300

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HTR Class 1

Rasp

Clearances 9

Regulation 21 CFR 878.4800

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JOT Class 2

Electrode, Gel, Electrosurgical

Clearances 9

Regulation 21 CFR 878.4400

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KGW Class 2

Ring (Wound Protector), Drape Retention, Internal

Clearances 9

Regulation 21 CFR 878.4370

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OXZ Class 2

Pediatric/Child Facemask

Clearances 9

Regulation 21 CFR 878.4040

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PAG Class 2

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Clearances 9

Regulation 21 CFR 878.3300

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FSH Class 1

Tray, Surgical, Needle

Clearances 8

Regulation 21 CFR 878.4800

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FSW Class 2

Light, Surgical, Endoscopic

Clearances 8

Regulation 21 CFR 878.4580

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FYH Class 1

Splint, Extremity, Noninflatable, External, Sterile

Clearances 8

Regulation 21 CFR 878.3910

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FZW Class 1

Expander, Surgical, Skin Graft

Clearances 8

Regulation 21 CFR 878.4800

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GAB Class 1

Needle, Suturing, Disposable

Clearances 8

Regulation 21 CFR 878.4800

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GBB Class 1

Chair, Surgical, Ac-Powered

Clearances 8

Regulation 21 CFR 878.4960

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GBQ Class 1

Catheter, Continuous Irrigation

Clearances 8

Regulation 21 CFR 878.4200

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GCD Class 1

Connector, Catheter

Clearances 8

Regulation 21 CFR 878.4200

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KGL Class 2

Cabinet, Phototherapy (Puva)

Clearances 8

Regulation 21 CFR 878.4630

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LXI Class 1

Guide, Drill, Ligament

Clearances 8

Regulation 21 CFR 878.4820

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NWJ Class 2

Suture, Recombinant Technology

Clearances 8

Regulation 21 CFR 878.4494

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ONO Class 2

Neurosurgical Laser With Mr Thermography

Clearances 8

Regulation 21 CFR 878.4810

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OXC Class 2

Mesh, Surgical, Absorbable, Staple Line Reinforcement

Clearances 8

Regulation 21 CFR 878.3300

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OXF Class 2

Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Clearances 8

Regulation 21 CFR 878.3300

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PZP Class 2

Fluid Jet Removal System

Clearances 8

Regulation 21 CFR 876.4350

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SAH Class 2

Magnetic Compression Anastomosis System

Clearances 8

Regulation 21 CFR 878.4816

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FSQ Class 2

Light, Surgical, Instrument

Clearances 7

Regulation 21 CFR 878.4580

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FYE Class 1

Dress, Surgical

Clearances 7

Regulation 21 CFR 878.4040

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FZF Class 1

Splint, Extremity, Inflatable, External

Clearances 7

Regulation 21 CFR 878.3900

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GAH Class 1

Stylet, Surgical, General & Plastic Surgery

Clearances 7

Regulation 21 CFR 878.4800

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GAN Class 2

Suture, Absorbable, Synthetic

Clearances 7

Regulation 21 CFR 878.4830

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GCB Class 1

Needle, Catheter

Clearances 7

Regulation 21 CFR 878.4200

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GDI Class 1

Dissector, Surgical, General & Plastic Surgery

Clearances 7

Regulation 21 CFR 878.4800

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GEE Class 1

Brush, Biopsy, General & Plastic Surgery

Clearances 7

Regulation 21 CFR 878.4800

View devices →

HMT Class 2

Drape, Patient, Ophthalmic

Clearances 7

Regulation 21 CFR 878.4370

View devices →

JDJ Class 2

Mesh, Surgical, Acetabular, Hip, Prosthesis

Clearances 7

Regulation 21 CFR 878.3300

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LRY Class 1

Punch, Surgical

Clearances 7

Regulation 21 CFR 878.4800

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MJG Class 1

Device, Percutaneous, Biopsy

Clearances 7

Regulation 21 CFR 878.4800

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MVR Class 2

Device, Anastomotic, Microvascular

Clearances 7

Regulation 21 CFR 878.4300

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NWA Class 2

Prosthesis, Tracheal, Preformed/Molded

Clearances 7

Regulation 21 CFR 878.3720

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ONE Class 2

Powered Light Based Non-Laser Surgical Instrument

Clearances 7

Regulation 21 CFR 878.4810

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PBY Class 2

Temporary Tissue Marker

Clearances 7

Regulation 21 CFR 878.4300

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PNL Class 2

Magnetic Surgical System

Clearances 7

Regulation 21 CFR 878.4815

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PZL Class 2

Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Clearances 7

Regulation 21 CFR 878.4685

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QJF Class 2

Autofluorescence Imaging Adjunct Tool For Wounds

Clearances 7

Regulation 21 CFR 878.4550

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QNM Class 2

Mountable Electromechanical Surgical System For Transluminal Approaches

Clearances 7

Regulation 21 CFR 878.4961

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FWB Class 1

Camera, Television, Surgical, Without Audio

Clearances 6

Regulation 21 CFR 878.4160

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FWW Class 1

Table, Operating-Room, Pneumatic

Clearances 6

Regulation 21 CFR 878.4960

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FXO Class 1

Suit, Surgical

Clearances 6

Regulation 21 CFR 878.4040

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FYB Class 2

Gown, Patient

Clearances 6

Regulation 21 CFR 878.4040

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FZQ Class 1

Clip, Removable (Skin)

Clearances 6

Regulation 21 CFR 878.4320

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GDH Class 1

Gouge, Surgical, General & Plastic Surgery

Clearances 6

Regulation 21 CFR 878.4800

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GFI Class 1

Osteotome, Manual

Clearances 6

Regulation 21 CFR 878.4800

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KGY Class 1

Bag, Intestine

Clearances 6

Regulation 21 CFR 878.4100

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KPK Class 2

Marker, Ostia, Aorto-Saphenous Vein

Clearances 6

Regulation 21 CFR 878.4650

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MKY Class 1

System, Skin Closure

Clearances 6

Regulation 21 CFR 878.4320

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MUM Class 2

Stent, Metallic, Expandable, Duodenal

Clearances 6

Regulation 21 CFR 878.3610

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NRB Class 2

Wound Cleaner, Ultrasound

Clearances 6

Regulation 21 CFR 878.4410

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NTB Class 2

System, Ablation, Ultrasound And Accessories

Clearances 6

Regulation 21 CFR 878.4400

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OMD Class 2

Cutaneous Tissue Adhesive With Mesh

Clearances 6

Regulation 21 CFR 878.4011

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ORC Class 2

Air Filter Portable Apparatus

Clearances 6

Regulation 21 CFR 878.5070

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ORQ Class 2

Mesh, Surgical, Deployer

Clearances 6

Regulation 21 CFR 878.3300

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OTK Class 2

Wound Drain Catheter System

Clearances 6

Regulation 21 CFR 878.4780

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OUP Class 2

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Clearances 6

Regulation 21 CFR 878.4790

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PMC Class 2

Scalp Cooling System

Clearances 6

Regulation 21 CFR 878.4360

View devices →

PQM Class 2

Surgical Smoke Precipitator

Clearances 6

Regulation 21 CFR 878.5050

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EYF Class 1

Protector, Wound, Plastic

Clearances 5

Regulation 21 CFR 878.4014

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FQP Class 2

Lamp, Operating-Room

Clearances 5

Regulation 21 CFR 878.4580

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FWD Class 1

Camera, Television, Microsurgical, Without Audio

Clearances 5

Regulation 21 CFR 878.4160

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FZI Class 2

Apparatus, Air Handling, Enclosure

Clearances 5

Regulation 21 CFR 878.5070

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GAF Class 1

Spatula, Surgical, General & Plastic Surgery

Clearances 5

Regulation 21 CFR 878.4800

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GBA Class 1

Catheter, Balloon Type

Clearances 5

Regulation 21 CFR 878.4200

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GCC Class 1

Dilator, Catheter

Clearances 5

Regulation 21 CFR 878.4200

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GCZ Class 1

Retainer, Surgical

Clearances 5

Regulation 21 CFR 878.4800

View devices →

GDL Class 1

Needle, Suturing, Reusable

Clearances 5

Regulation 21 CFR 878.4800

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GEJ Class 1

Carrier, Ligature

Clearances 5

Regulation 21 CFR 878.4800

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ONT Class 2

N95 Respirator With Antimicrobial/Antiviral Agent

Clearances 5

Regulation 21 CFR 878.4040

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OWX Class 2

Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon

Clearances 5

Regulation 21 CFR 878.3300

View devices →

PGZ Class 2

Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

Clearances 5

Regulation 21 CFR 878.4452

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POD Class 2

Temporary, Internal Use Hemostatic

Clearances 5

Regulation 21 CFR 878.4454

View devices →

QDG Class 2

Parathyroid Autofluorescence Imaging Device

Clearances 5

Regulation 21 CFR 878.4550

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QUW Class 2

Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

Clearances 5

Regulation 21 CFR 878.3300

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DWG Class 2

Electrosurgical Device

Clearances 4

Regulation 21 CFR 878.4400

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DWH Class 1

Blade, Saw, Surgical, Cardiovascular

Clearances 4

Regulation 21 CFR 878.4820

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FSP Class 1

Loupe, Diagnostic/Surgical

Clearances 4

Regulation 21 CFR 878.4800

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FTF Class 2

Illuminator, Non-Remote

Clearances 4

Regulation 21 CFR 878.4580

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FWY Class 1

Table, Operating-Room, Non-Electrical

Clearances 4

Regulation 21 CFR 878.4950

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FXN Class 1

Tape, Camera, Surgical

Clearances 4

Regulation 21 CFR 878.4160

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FYI Class 1

Appliance, Facial Fracture, External

Clearances 4

Regulation 21 CFR 878.3250

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FZH Class 2

Apparatus, Air Handling, Room

Clearances 4

Regulation 21 CFR 878.5070

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GAE Class 1

Snare, Surgical

Clearances 4

Regulation 21 CFR 878.4800

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GAO Class 2

Suture, Nonabsorbable

Clearances 4

Regulation 21 CFR 878.4495

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GBC Class 2

Lamp, Surgical, Incandescent

Clearances 4

Regulation 21 CFR 878.4580

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GBJ Class 1

Prosthesis, Adhesive, External

Clearances 4

Regulation 21 CFR 878.3750

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GCE Class 1

Adaptor, Catheter

Clearances 4

Regulation 21 CFR 878.4200

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GEF Class 1

Applier, Staple, Surgical,

Clearances 4

Regulation 21 CFR 878.4800

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HBT Class 1

Applier, Hemostatic Clip

Clearances 4

Regulation 21 CFR 878.4800

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HCF Class 1

Instrument, Ligature Passing And Knot Tying

Clearances 4

Regulation 21 CFR 878.4800

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HMW Class 2

Drape, Microscope, Ophthalmic

Clearances 4

Regulation 21 CFR 878.4370

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HXR Class 1

Spatula, Orthopedic

Clearances 4

Regulation 21 CFR 878.4800

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KFK Class 1

Saw, Pneumatically Powered

Clearances 4

Regulation 21 CFR 878.4820

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LWG Class 1

Surgical Table Cushion

Clearances 4

Regulation 21 CFR 878.4950

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LWK Class 1

Razor, Surgical

Clearances 4

Regulation 21 CFR 878.4800

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NAC Class 1

Dressing, Wound, Hydrophilic

Clearances 4

Regulation 21 CFR 878.4018

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NZP Class 2

Sealant, Microbial

Clearances 4

Regulation 21 CFR 878.4370

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ONQ Class 2

Electrosurgical Coagulation For Aesthetic

Clearances 4

Regulation 21 CFR 878.4400

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OUK Class 2

Surgical Mask With Antimicrobial/Antiviral Agent

Clearances 4

Regulation 21 CFR 878.4040

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OXE Class 2

Mesh, Surgical, Collagen, Staple Line Reinforcement

Clearances 4

Regulation 21 CFR 878.3300

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OXH Class 2

Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

Clearances 4

Regulation 21 CFR 878.3300

View devices →

QVJ Class 2

Low Power Electrosurgical Devices For Skin Lesion Destruction

Clearances 4

Regulation 21 CFR 878.4400

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SAQ Class 2

Electromechanical System For Open Microsurgery

Clearances 4

Regulation 21 CFR 878.4963

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SDD Class 2

Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

Clearances 4

Regulation 21 CFR 878.4965

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BWA Class 2

Unit, Electrosurgical And Coagulation, With Accessories

Clearances 3

Regulation 21 CFR 878.4400

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BWP Class 1

Shoe And Shoe Cover, Conductive

Clearances 3

Regulation 21 CFR 878.4040

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FWC Class 1

Camera, Television, Surgical, With Audio

Clearances 3

Regulation 21 CFR 878.4160

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FWX Class 1

Table, Operating-Room, Mechanical

Clearances 3

Regulation 21 CFR 878.4950

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FZD Class 2

Prosthesis, Ear, Internal

Clearances 3

Regulation 21 CFR 878.3590

View devices →

GBP Class 1

Catheter, Multiple Lumen

Clearances 3

Regulation 21 CFR 878.4200

View devices →

GFG Class 1

Bit, Surgical

Clearances 3

Regulation 21 CFR 878.4820

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GFJ Class 1

Mallet, Surgical, General & Plastic Surgery

Clearances 3

Regulation 21 CFR 878.4800

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HJE Class 2

Lamp, Fluorescein, Ac-Powered

Clearances 3

Regulation 21 CFR 878.4580

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HTF Class 1

Curette

Clearances 3

Regulation 21 CFR 878.4800

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HWM Class 1

Osteotome

Clearances 3

Regulation 21 CFR 878.4800

View devices →

HXL Class 1

Mallet

Clearances 3

Regulation 21 CFR 878.4800

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LRZ Class 1

Screwdriver, Surgical

Clearances 3

Regulation 21 CFR 878.4800

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MCH Class 2

Clip, Hemostatic

Clearances 3

Regulation 21 CFR 878.4300

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MOQ Class 1

Battery, Replacement, Rechargeable

Clearances 3

Regulation 21 CFR 878.4820

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MUK Class 2

Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue

Clearances 3

Regulation 21 CFR 878.4400

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NCA Class 2

Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

Clearances 3

Regulation 21 CFR 878.4300

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NLL Class 2

Staple, Implantable, Reprocessed

Clearances 3

Regulation 21 CFR 878.4750

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NYT Class 2

Prosthesis, Tracheal, Expandable, Polymeric

Clearances 3

Regulation 21 CFR 878.3720

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ODR Class 2

Electrosurgical Patient Return Electrode

Clearances 3

Regulation 21 CFR 878.4400

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OKJ Class 2

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

Clearances 3

Regulation 21 CFR 878.4860

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OLC Class 2

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Clearances 3

Regulation 21 CFR 878.3300

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OUH Class 2

Skin Resurfacing Rf Applicator

Clearances 3

Regulation 21 CFR 878.4400

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OXD Class 2

Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement

Clearances 3

Regulation 21 CFR 878.3300

View devices →

SCV Class 2

Modular Electromechanical Surgical System

Clearances 3

Regulation 21 CFR 878.4964

View devices →

DWI Class 1

Saw, Electrically Powered

Clearances 2

Regulation 21 CFR 878.4820

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EPW Class 1

Support, Head, Surgical, Ent

Clearances 2

Regulation 21 CFR 878.4950

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ESF Class 2

Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent

Clearances 2

Regulation 21 CFR 878.3500

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EYR Class 1

Tourniquet, Gastro-Urology

Clearances 2

Regulation 21 CFR 878.5900

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EYY Class 2

Drape, Urological, Disposable

Clearances 2

Regulation 21 CFR 878.4370

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FGY Class 1

Cannula, Injection

Clearances 2

Regulation 21 CFR 878.4200

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FHM Class 1

Apparatus, Suturing, Stomach And Intestinal

Clearances 2

Regulation 21 CFR 878.4800

View devices →

FNW Class 2

Pad, Kelly

Clearances 2

Regulation 21 CFR 878.4370

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FTG Class 2

Illuminator, Remote

Clearances 2

Regulation 21 CFR 878.4580

View devices →

FTS Class 1

Camera, Cine, Endoscopic, With Audio

Clearances 2

Regulation 21 CFR 878.4160

View devices →

FWG Class 1

Camera, Television, Endoscopic, With Audio

Clearances 2

Regulation 21 CFR 878.4160

View devices →

FWH Class 1

Camera, Cine, Surgical, Without Audio

Clearances 2

Regulation 21 CFR 878.4160

View devices →

FWL Class 1

Camera, Cine, Endoscopic, Without Audio

Clearances 2

Regulation 21 CFR 878.4160

View devices →

FXR Class 1

Holder, Camera, Surgical

Clearances 2

Regulation 21 CFR 878.4160

View devices →

FZK Class 1

Chair, Surgical, Non-Electrical

Clearances 2

Regulation 21 CFR 878.4950

View devices →

FZO Class 1

Chisel, Surgical, Manual

Clearances 2

Regulation 21 CFR 878.4800

View devices →

GAC Class 1

Rasp, Surgical, General & Plastic Surgery

Clearances 2

Regulation 21 CFR 878.4800

View devices →

GBN Class 1

Catheter, Pediatric, General & Plastic Surgery

Clearances 2

Regulation 21 CFR 878.4200

View devices →

GDR Class 1

Saw, Manual And Accessories

Clearances 2

Regulation 21 CFR 878.4800

View devices →

GED Class 1

Brush, Dermabrasion, Manual

Clearances 2

Regulation 21 CFR 878.4800

View devices →

GEO Class 1

File, Surgical, General & Plastic Surgery

Clearances 2

Regulation 21 CFR 878.4800

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GFC Class 1

Driver, Surgical, Pin

Clearances 2

Regulation 21 CFR 878.4820

View devices →

GFE Class 1

Brush, Dermabrasion, Powered

Clearances 2

Regulation 21 CFR 878.4820

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HAB Class 1

Saw, Powered, And Accessories

Clearances 2

Regulation 21 CFR 878.4820

View devices →

JYC Class 1

Cannula, Ear

Clearances 2

Regulation 21 CFR 878.4800

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KAG Class 1

Holder, Speculum, Ent

Clearances 2

Regulation 21 CFR 878.1800

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LXZ Class 1

Guard, Instrument

Clearances 2

Regulation 21 CFR 878.4800

View devices →

LYV Class 1

Label Or Tag, Sterile

Clearances 2

Regulation 21 CFR 878.4800

View devices →

LZM Class 1

Guard, Skin Graft

Clearances 2

Regulation 21 CFR 878.4014

View devices →

MAC Class 1

Decontamination Kit

Clearances 2

Regulation 21 CFR 878.4014

View devices →

MNF Class 2

Implant, Temporal

Clearances 2

Regulation 21 CFR 878.3550

View devices →

MSA Class 1

Dressing, Wound And Burn, Occlusive, Heated

Clearances 2

Regulation 21 CFR 878.4020

View devices →

MWY Class 2

System, Microwave, Hair Removal

Clearances 2

Regulation 21 CFR 878.4400

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MXW Class 2

Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

Clearances 2

Regulation 21 CFR 878.5010

View devices →

NJC Class 2

Clip, Vas Deferens

Clearances 2

Regulation 21 CFR 878.4300

View devices →

NJU Class 2

Suture, Nonabsorbable, Nitinol

Clearances 2

Regulation 21 CFR 878.4495

View devices →

OUB Class 2

Instrument For Treatment Of Hyperhidrosis

Clearances 2

Regulation 21 CFR 878.4400

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OXK Class 2

Mesh, Surgical, Collagen, Large Abdominal Wall Defects

Clearances 2

Regulation 21 CFR 878.3300

View devices →

OYW Class 2

Laser, Cellulite Appearance

Clearances 2

Regulation 21 CFR 878.4810

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PAJ Class 2

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Clearances 2

Regulation 21 CFR 878.3300

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PQN Class 2

Carbon Dioxide Gas Controlled Tissue Expander

Clearances 2

Regulation 21 CFR 878.3510

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QCY Class 2

Laser Absorbing Particles

Clearances 2

Regulation 21 CFR 878.4810

View devices →

QFC Class 2

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Clearances 2

Regulation 21 CFR 878.4783

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QGM Class 2

Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

Clearances 2

Regulation 21 CFR 878.4405

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QPZ Class 2

Contact Cooling For Skin Lesion Pain Relief

Clearances 2

Regulation 21 CFR 878.4340

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EYX Class 2

Drape, Pure Latex Sheet, With Self-Retaining Finger Cot

Clearances 1

Regulation 21 CFR 878.4370

View devices →

FHR Class 1

Needle, Gastro-Urology

Clearances 1

Regulation 21 CFR 878.4800

View devices →

FTT Class 1

Camera, Still, Surgical

Clearances 1

Regulation 21 CFR 878.4160

View devices →

FTX Class 1

Mirror, General & Plastic Surgery

Clearances 1

Regulation 21 CFR 878.4800

View devices →

FXF Class 1

Speculum, Illuminated

Clearances 1

Regulation 21 CFR 878.1800

View devices →

FXG Class 1

Specula Accessories

Clearances 1

Regulation 21 CFR 878.1800

View devices →

FXM Class 1

Camera, Still, Endoscopic

Clearances 1

Regulation 21 CFR 878.4160

View devices →

FXQ Class 1

Lens, Camera, Surgical

Clearances 1

Regulation 21 CFR 878.4160

View devices →

FXW Class 1

Shoes, Operating-Room

Clearances 1

Regulation 21 CFR 878.4040

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FZG Class 2

Apparatus, Air Handling, Bench

Clearances 1

Regulation 21 CFR 878.5070

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FZM Class 1

Stool, Operating-Room

Clearances 1

Regulation 21 CFR 878.4950

View devices →

FZY Class 1

Hammer, Surgical

Clearances 1

Regulation 21 CFR 878.4800

View devices →

GAK Class 2

Suture, Absorbable

Clearances 1

Regulation 21 CFR 878.4830

View devices →

GDN Class 1

Knife, Amputation

Clearances 1

Regulation 21 CFR 878.4800

View devices →

JCQ Class 2

Prosthesis, Esophagus

Clearances 1

Regulation 21 CFR 878.3610

View devices →

JYD Class 1

Chisel, Mastoid

Clearances 1

Regulation 21 CFR 878.4800

View devices →

JYK Class 1

Holder, Ear Speculum

Clearances 1

Regulation 21 CFR 878.1800

View devices →

KDA Class 2

Prosthesis, Ptfe/Carbon-Fiber

Clearances 1

Regulation 21 CFR 878.3500

View devices →

KGQ Class 1

Cream, Gloving, Surgeon'S

Clearances 1

Regulation 21 CFR 878.4470

View devices →

KGT Class 1

Drape, Adhesive, Aerosol

Clearances 1

Regulation 21 CFR 878.4380

View devices →

KIK Class 1

Hook, Bone

Clearances 1

Regulation 21 CFR 878.4800

View devices →

LSA Class 1

Vise, Bench, Surgical

Clearances 1

Regulation 21 CFR 878.4800

View devices →

LXK Class 1

Scrapper, Skin Specimen

Clearances 1

Regulation 21 CFR 878.4800

View devices →

MAW Class 1

Marker, Suture Identification

Clearances 1

Regulation 21 CFR 878.4800

View devices →

MCA Class 2

Tape, Surgical, Internal

Clearances 1

Regulation 21 CFR 878.3300

View devices →

MGO Class 1

Closure, Wound, Adhesive

Clearances 1

Regulation 21 CFR 878.4018

View devices →

MXG Class 2

Lamp, Uvc, (For Treating Skin And Wounds)

Clearances 1

Regulation 21 CFR 878.4630

View devices →

NEH Class 2

Anchor, Fascial

Clearances 1

Regulation 21 CFR 878.4300

View devices →

NMJ Class 2

Clip, Implantable, Reprocessed

Clearances 1

Regulation 21 CFR 878.4300

View devices →

NRJ Class 2

Ultrasound, Skin Permeation

Clearances 1

Regulation 21 CFR 878.4410

View devices →

NVH Class 2

Suture, Knot, Mechanical

Clearances 1

Regulation 21 CFR 878.4300

View devices →

NVJ Class 2

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

Clearances 1

Regulation 21 CFR 878.4400

View devices →

NWF Class 1

Drill, Battery Powered, Subungual Hematoma

Clearances 1

Regulation 21 CFR 878.4820

View devices →

OAJ Class 1

Catheter, Drainage, Intraoral/Extraoral

Clearances 1

Regulation 21 CFR 878.4200

View devices →

ODU Class 2

Facial Implant

Clearances 1

Regulation 21 CFR 878.3500

View devices →

OEI Class 2

Drainage Catheter With Antibiotic

Clearances 1

Regulation 21 CFR 878.4780

View devices →

OJU Class 1

Skin Prep Tray

Clearances 1

Regulation 21 CFR 878.4800

View devices →

OLL Class 2

Septal Stapler/Absorbable Staples

Clearances 1

Regulation 21 CFR 878.4750

View devices →

OMT Class 2

Absorbable Lung Biopsy Plug

Clearances 1

Regulation 21 CFR 878.4755

View devices →

OQL Class 2

Mesh, Surgical, Deployment Balloon

Clearances 1

Regulation 21 CFR 878.3300

View devices →

ORK Class 2

Laser Assisted Lipolysis

Clearances 1

Regulation 21 CFR 878.4810

View devices →

OVR Class 1

Kit, First Aid, Talking

Clearances 1

Regulation 21 CFR 878.4014

View devices →

OWR Class 2

Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery

Clearances 1

Regulation 21 CFR 878.3300

View devices →

OXJ Class 2

Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

Clearances 1

Regulation 21 CFR 878.3300

View devices →

OXN Class 2

Mesh, Surgical, Collagen, Fistula

Clearances 1

Regulation 21 CFR 878.3300

View devices →

PDG Class 2

Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

Clearances 1

Regulation 21 CFR 878.4400

View devices →

PDW Class 2

Internal Tissue Marker

Clearances 1

Regulation 21 CFR 878.4670

View devices →

PFP Class 1

Silicone Hydrogel For Scar Management

Clearances 1

Regulation 21 CFR 878.4025

View devices →

PIJ Class 2

Collagen Surgical Mesh Containing Drugs

Clearances 1

Regulation 21 CFR 878.3300

View devices →

PIR Class 1

Mercy Tape 2d And 3d Models

Clearances 1

Regulation 21 CFR 878.4800

View devices →

PKO Class 2

Transparent Patch For Use In Treatment Of Tattoos

Clearances 1

Regulation 21 CFR 878.4810

View devices →

PQI Class 2

Wound Retraction And Protection System

Clearances 1

Regulation 21 CFR 878.4371

View devices →

PYE Class 1

Staple Removal Kit

Clearances 1

Regulation 21 CFR 878.4760

View devices →

QBW Class 2

Surgical Apparel With Material Claims

Clearances 1

Regulation 21 CFR 878.4040

View devices →

QPX Class 2

Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical

Clearances 1

Regulation 21 CFR 878.4683

View devices →

QQO Class 1

Cranial Measurement Software

Clearances 1

Regulation 21 CFR 878.4800

View devices →

QSO Class 2

Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Clearances 1

Regulation 21 CFR 878.4040

View devices →

QUQ Class 2

Knife, Intraocular Pressure Lowering

Clearances 1

Regulation 21 CFR 878.4400

View devices →

QVS Class 2

Breast Implant Suction Retrieval Device

Clearances 1

Regulation 21 CFR 878.4675

View devices →

QWJ Class 2

Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament

Clearances 1

Regulation 21 CFR 878.3300

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QZN Class 2

Multi-Photon Imaging

Clearances 1

Regulation 21 CFR 878.4580

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SAB Class 2

Table Mounted Miniaturized Electromechanical Surgical System

Clearances 1

Regulation 21 CFR 878.4962

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SAM Class 1

Battery-Powered Instruments Charged Through Sterile Barriers

Clearances 1

Regulation 21 CFR 878.4820

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SFG Class 1

Camera, Surgical, Measurement

Clearances 1

Regulation 21 CFR 878.4160

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SGZ Class 2

Ultraviolet Lamp Products

Clearances 1

Regulation 21 CFR 878.4635

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ERY Class 2

Drape, Surgical, Ent

Clearances 0

Regulation 21 CFR 878.4370

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FAZ Class 2

System, Cryosurgical, Liquid Nitrogen, For Urology

Clearances 0

Regulation 21 CFR 878.4350

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FLJ Class 2

Unit, Airflow, Laminar

Clearances 0

Regulation 21 CFR 878.5070

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FRT Class 2

Unit, Isolation, Surgical

Clearances 0

Regulation 21 CFR 878.5070

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FSX Class 2

Light, Surgical, Connector

Clearances 0

Regulation 21 CFR 878.4580

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FSZ Class 2

Light, Surgical, Carrier

Clearances 0

Regulation 21 CFR 878.4580

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FTH Class 1

Camera, Still, Microsurgical

Clearances 0

Regulation 21 CFR 878.4160

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FTN Class 1

Plastic Surgery And Accessories Kit

Clearances 0

Regulation 21 CFR 878.3925

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FTR Class 3

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Clearances 0

Regulation 21 CFR 878.3540

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FWE Class 1

Camera, Television, Microsurgical, With Audio

Clearances 0

Regulation 21 CFR 878.4160

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FWI Class 1

Camera, Cine, Surgical, With Audio

Clearances 0

Regulation 21 CFR 878.4160

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FWJ Class 1

Camera, Cine, Microsurgical, Without Audio

Clearances 0

Regulation 21 CFR 878.4160

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FWK Class 1

Camera, Cine, Microsurgical, With Audio

Clearances 0

Regulation 21 CFR 878.4160

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FWM Class 3

Prosthesis, Breast, Inflatable, Internal, Saline

Clearances 0

Regulation 21 CFR 878.3530

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FXE Class 1

Speculum, Non-Illuminated

Clearances 0

Regulation 21 CFR 878.1800

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FXS Class 1

Frame, Camera, Surgical

Clearances 0

Regulation 21 CFR 878.4160

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FXT Class 1

Film, Camera, Surgical

Clearances 0

Regulation 21 CFR 878.4160

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FXZ Class 1

Helmet, Surgical

Clearances 0

Regulation 21 CFR 878.4040

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FZR Class 1

Contractor, Surgical

Clearances 0

Regulation 21 CFR 878.4800

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GAI Class 1

Stripper, Vein, Reusable

Clearances 0

Regulation 21 CFR 878.4800

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GAJ Class 1

Stripper, Vein, Disposable

Clearances 0

Regulation 21 CFR 878.4800

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GBY Class 1

Catheter, Eustachian, General & Plastic Surgery

Clearances 0

Regulation 21 CFR 878.4200

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GFB Class 1

Head, Surgical, Hammer

Clearances 0

Regulation 21 CFR 878.4820

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HRB Class 1

Microscope, Operating, Non-Electric, Ophthalmic

Clearances 0

Regulation 21 CFR 878.4700

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HSO Class 1

Saw

Clearances 0

Regulation 21 CFR 878.4800

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HTE Class 1

Elevator

Clearances 0

Regulation 21 CFR 878.4800

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HXT Class 1

Tape, Orthopedic

Clearances 0

Regulation 21 CFR 878.4800

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HYA Class 1

Forceps, Wire Holding

Clearances 0

Regulation 21 CFR 878.4800

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KAN Class 1

Chisel, Nasal

Clearances 0

Regulation 21 CFR 878.4800

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KCE Class 1

Cannulae, Bronchial

Clearances 0

Regulation 21 CFR 878.4800

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KOY Class 1

Degreaser, Skin, Surgical

Clearances 0

Regulation 21 CFR 878.4730

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LMF Class 3

Agent, Absorbable Hemostatic, Collagen Based

Clearances 0

Regulation 21 CFR 878.4490

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LMG Class 3

Agent, Absorbable Hemostatic, Non-Collagen Based

Clearances 0

Regulation 21 CFR 878.4490

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MIJ Class 1

Needle, Tumor Localization

Clearances 0

Regulation 21 CFR 878.4800

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MUL Class 2

Generator, Electrosurgical, Coagulation, Cancer

Clearances 0

Regulation 21 CFR 878.4400

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NEJ Class 2

System, Cryosurgical, Liquid Nitrogen, For Gastroenterology

Clearances 0

Regulation 21 CFR 878.4350

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NJZ Class 1

Extractor, Vein

Clearances 0

Regulation 21 CFR 878.4800

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NLK Class 1

Needle, Biopsy, Cardiovascular, Reprocessed

Clearances 0

Regulation 21 CFR 878.4800

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NMT Class 1

Needle, Catheter, Reprocessed

Clearances 0

Regulation 21 CFR 878.4200

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NMU Class 1

Needle, Gastro-Urology, Reprocessed

Clearances 0

Regulation 21 CFR 878.4800

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NNA Class 1

Biopsy Device, Percutaneous, Reprocessed

Clearances 0

Regulation 21 CFR 878.4800

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NNC Class 1

Needle, Aspiration And Needle, Reprocessed

Clearances 0

Regulation 21 CFR 878.4800

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NOC Class 1

Splint, Extremity, Non-Inflatable, External, Non-Sterile

Clearances 0

Regulation 21 CFR 878.3910

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NOD Class 1

Board, Arm (With Cover), Non-Sterile

Clearances 0

Regulation 21 CFR 878.3910

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NOJ Class 1

Prosthesis, Breast, External, No Adhesive

Clearances 0

Regulation 21 CFR 878.3800

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NOK Class 1

Material, External Aesthetic Restoration, No Adhesive

Clearances 0

Regulation 21 CFR 878.3800

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NXF Class 1

Gas, Laser Generating

Clearances 0

Regulation 21 CFR 878.4810

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NYS Class 2

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Clearances 0

Regulation 21 CFR 878.4015

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OEA Class 1

Non-Surgical Gown

Clearances 0

Regulation 21 CFR 878.4040

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OEL Class 2

Laser, Benign Prostatic Hyperplasia

Clearances 0

Regulation 21 CFR 878.4810

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OHO Class 1

First Aid Kit Without Drug

Clearances 0

Regulation 21 CFR 878.4014

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OJH Class 1

Orthopedic Tray

Clearances 0

Regulation 21 CFR 878.4800

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OJJ Class 1

Burn Kit Without Drug

Clearances 0

Regulation 21 CFR 878.4022

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OJR Class 2

Vacuum Powered Body Fluid Collection Kit

Clearances 0

Regulation 21 CFR 878.4780

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OJS Class 1

Tourniquet Kit

Clearances 0

Regulation 21 CFR 878.5900

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OJT Class 1

Aspiration Tray

Clearances 0

Regulation 21 CFR 878.4800

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OJV Class 1

Single Use Instrument Tray

Clearances 0

Regulation 21 CFR 878.4800

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OJW Class 2

Shave Prep Kit

Clearances 0

Regulation 21 CFR 878.4370

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OKF Class 2

Body Fluid Disposal Kit

Clearances 0

Regulation 21 CFR 878.4040

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OKG Class 2

Body Fluid Clean Up Kit

Clearances 0

Regulation 21 CFR 878.4040

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OKH Class 2

Body Fluids Barrier Kit

Clearances 0

Regulation 21 CFR 878.4040

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OKI Class 2

Emergency Response Safety Kit

Clearances 0

Regulation 21 CFR 878.4040

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ONV Class 2

Electrical Impedance Spectrometer

Clearances 0

Regulation 21 CFR 878.1820

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OVN Class 2

Suture Kit

Clearances 0

Regulation 21 CFR 878.4830

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OWS Class 2

Mesh, Surgical, Collagen, Plastics, Facial Implants

Clearances 0

Regulation 21 CFR 878.3300

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OWU Class 2

Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia

Clearances 0

Regulation 21 CFR 878.3300

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OWV Class 2

Mesh, Surgical, Collagen, Diaphragmatic Hernia

Clearances 0

Regulation 21 CFR 878.3300

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OWZ Class 2

Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction

Clearances 0

Regulation 21 CFR 878.3300

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OXA Class 2

Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction

Clearances 0

Regulation 21 CFR 878.3300

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OXB Class 2

Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction

Clearances 0

Regulation 21 CFR 878.3300

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OXG Class 2

Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery

Clearances 0

Regulation 21 CFR 878.3300

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OXI Class 2

Mesh, Surgical, Absorbable, Large Abdominal Wall Defects

Clearances 0

Regulation 21 CFR 878.3300

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OXL Class 2

Mesh, Surgical, Absorbable, Organ Support

Clearances 0

Regulation 21 CFR 878.3300

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OXM Class 2

Mesh, Surgical, Absorbable, Fistula

Clearances 0

Regulation 21 CFR 878.3300

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OXT Class 2

Percutaneous Surgical Set With Attachments

Clearances 0

Regulation 21 CFR 878.4805

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OYD Class 2

Optical Diagnostic Device For Melanoma Detection

Clearances 0

Regulation 21 CFR 878.1820

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PBD Class f

Composite Cultured Skin

Clearances 0

Regulation 21 CFR 878.4024

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PJK Class 3

Tissue Adhesive For Internal Use

Clearances 0

Regulation 21 CFR 878.4010

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PKD Class 1

Laceration Tray

Clearances 0

Regulation 21 CFR 878.4014

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PKE Class 1

Laparoscopic Cholecystectomy Kit

Clearances 0

Regulation 21 CFR 878.4800

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PLJ Class 3

Tissue Adhesive Internal Use

Clearances 0

Regulation 21 CFR 878.4010

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PLY Class 2

Antimicrobial Drapes

Clearances 0

Regulation 21 CFR 878.4370

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PMX Class 3

Absorbable Collagen Hemostatic Agent With Thrombin

Clearances 0

Regulation 21 CFR 878.4490

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PPP Class 1

Disposable Joint Aspiration/Injection Kit

Clearances 0

Regulation 21 CFR 878.4800

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PTX Class 2

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Clearances 0

Regulation 21 CFR 878.4495

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PUI Class 2

Drape, Surgical, Exempt

Clearances 0

Regulation 21 CFR 878.4370

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PXN Class 1

Basic Set-Up Tray

Clearances 0

Regulation 21 CFR 878.4800

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PXO Class 1

Bone Marrow Biopsy Tray

Clearances 0

Regulation 21 CFR 878.4800

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PXP Class 1

Breast Biopsy / Localization Tray

Clearances 0

Regulation 21 CFR 878.4800

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PXQ Class 1

Burn Dressing Tray

Clearances 0

Regulation 21 CFR 878.4022

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PXR Class 1

Cement And Bone Removal Kit

Clearances 0

Regulation 21 CFR 878.4820

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PXS Class 1

Cholecystectomy Kit

Clearances 0

Regulation 21 CFR 878.4800

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PXU Class 1

Fluid Drainage Tray

Clearances 0

Regulation 21 CFR 878.4200

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PXV Class 1

General Purpose Instrument Tray

Clearances 0

Regulation 21 CFR 878.4800

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PXW Class 1

Herniorraphy Kit

Clearances 0

Regulation 21 CFR 878.4800

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PXX Class 1

Incision Tray

Clearances 0

Regulation 21 CFR 878.4800

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PXY Class 1

Irrigation Kit (Wounds)

Clearances 0

Regulation 21 CFR 878.4014

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PXZ Class 1

Laparascopic Sphincterotomy Kit

Clearances 0

Regulation 21 CFR 878.4800

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PYA Class 1

Liver Biopsy Kit

Clearances 0

Regulation 21 CFR 878.4800

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PYB Class 1

Minor Surgical Procedures Tray

Clearances 0

Regulation 21 CFR 878.4800

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PYC Class 1

Paracentesis Tray

Clearances 0

Regulation 21 CFR 878.4200

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PYD Class 1

Pelviscopy Kit

Clearances 0

Regulation 21 CFR 878.4800

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PYF Class 1

Sterile Puncture Tray

Clearances 0

Regulation 21 CFR 878.4800

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PYG Class 1

Suction Catheter Kit

Clearances 0

Regulation 21 CFR 878.4200

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PYH Class 1

Surgical Retractor Kit

Clearances 0

Regulation 21 CFR 878.4800

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PYI Class 1

Thoracic Catheter Insertion Tray

Clearances 0

Regulation 21 CFR 878.4200

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PYJ Class 1

Ulcer Wound Tray

Clearances 0

Regulation 21 CFR 878.4014

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PYK Class 1

Venous Ulcer Kit

Clearances 0

Regulation 21 CFR 878.4014

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PYL Class 1

Wound Drainage Kit

Clearances 0

Regulation 21 CFR 878.4014

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PYU Class 1

Sponge, Eyelid Cleaning, Powered

Clearances 0

Regulation 21 CFR 878.4820

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PZQ Class 2

General Laparoscopic Power Morcellation Containment System

Clearances 0

Regulation 21 CFR 878.4825

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QCR Class 1

Wound Autofluorescence Imaging Device

Clearances 0

Regulation 21 CFR 878.4165

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QDF Class 2

Parathyroid Autofluorescence Detection Device

Clearances 0

Regulation 21 CFR 878.4550

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QGI Class 1

Air-Handling Apparatus Accessory

Clearances 0

Regulation 21 CFR 878.5080

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QGX Class 1

General Use Pneumatic Tourniquet

Clearances 0

Regulation 21 CFR 878.5910

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QHF Class 2

Energy Based Device For Treatment Of Tattoos

Clearances 0

Regulation 21 CFR 878.4810

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QKL Class 2

Lipoaspirate Washing System For Aesthetic Body Contouring

Clearances 0

Regulation 21 CFR 878.5040

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QML Class 2

Anal Fistula Closure Device

Clearances 0

Regulation 21 CFR 878.4835

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QMX Class 1

Label Or Tag, Non-Sterile

Clearances 0

Regulation 21 CFR 878.4800

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QPE Class 2

Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

Clearances 0

Regulation 21 CFR 878.4880

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QRM Class 3

Multiple Use Blood Lancet For Multiple Patient Use

Clearances 0

Regulation 21 CFR 878.4850

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QUB Class 2

Suction Lipoplasty System For Removal And Transfer

Clearances 0

Regulation 21 CFR 878.5040

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QVX Class 2

Skin Patch For Treatment Of Hyperhidrosis

Clearances 0

Regulation 21 CFR 878.4425

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QXW Class 2

Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer

Clearances 0

Regulation 21 CFR 878.4355

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QYK Class 2

Semi-Automated Autologous Skin Graft Harvesting And Application Device

Clearances 0

Regulation 21 CFR 878.4795

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QZS Class 2

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Clearances 0

Regulation 21 CFR 878.1830

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RAB Class 2

Sunlamp Products (Pre-Standard)

Clearances 0

Regulation 21 CFR 878.4635

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REF Class 2

Suntan Bed

Clearances 0

Regulation 21 CFR 878.4635

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REG Class 2

Suntan Lamp

Clearances 0

Regulation 21 CFR 878.4635

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REH Class 2

Tabletop Sunlamp System

Clearances 0

Regulation 21 CFR 878.4635

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SFQ Class 2

Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision

Clearances 0

Regulation 21 CFR 878.4400

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SGV Class 3

Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

Clearances 0

Regulation 21 CFR 878.4490

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SHA Class 2

Solid Wound Dressing With Permanently Bound Antimicrobial Agent

Clearances 0

Regulation 21 CFR 878.4013

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SHY Class 2

Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

Clearances 0

Regulation 21 CFR 878.1840

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SIR Class 2

Integrated Operating Table-Electromechanical Surgical System

Clearances 0

Regulation 21 CFR 878.4966

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