Gastroenterology, Urology Device Classification Codes

GCJ Class 2

Laparoscope, General & Plastic Surgery

Clearances 1385

Regulation 21 CFR 876.1500

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KNT Class 2

Tubes, Gastrointestinal (And Accessories)

Clearances 625

Regulation 21 CFR 876.5980

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FGE Class 2

Stents, Drains And Dilators For The Biliary Ducts

Clearances 462

Regulation 21 CFR 876.5010

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KNW Class 2

Instrument, Biopsy

Clearances 347

Regulation 21 CFR 876.1075

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KDI Class 2

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Clearances 332

Regulation 21 CFR 876.5860

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KOD Class 2

Catheter, Urological

Clearances 237

Regulation 21 CFR 876.5130

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KNX Class 2

Collector, Urine, (And Accessories) For Indwelling Catheter

Clearances 206

Regulation 21 CFR 876.5250

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KNS Class 2

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Clearances 185

Regulation 21 CFR 876.4300

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KOC Class 2

Accessories, Blood Circuit, Hemodialysis

Clearances 179

Regulation 21 CFR 876.5820

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NAY Class 2

System, Surgical, Computer Controlled Instrument

Clearances 154

Regulation 21 CFR 876.1500

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FJI Class 2

Dialyzer, Capillary, Hollow Fiber

Clearances 131

Regulation 21 CFR 876.5820

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EZL Class 2

Catheter, Retention Type, Balloon

Clearances 125

Regulation 21 CFR 876.5130

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FCG Class 2

Biopsy Needle

Clearances 124

Regulation 21 CFR 876.1075

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FAD Class 2

Stent, Ureteral

Clearances 121

Regulation 21 CFR 876.4620

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KPO Class 2

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Clearances 121

Regulation 21 CFR 876.5820

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FGB Class 2

Ureteroscope And Accessories, Flexible/Rigid

Clearances 116

Regulation 21 CFR 876.1500

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MSD Class 2

Catheter, Hemodialysis, Implanted

Clearances 115

Regulation 21 CFR 876.5540

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FIP Class 2

Subsystem, Water Purification

Clearances 111

Regulation 21 CFR 876.5665

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KDJ Class 2

Set, Administration, For Peritoneal Dialysis, Disposable

Clearances 111

Regulation 21 CFR 876.5630

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FDF Class 2

Colonoscope And Accessories, Flexible/Rigid

Clearances 107

Regulation 21 CFR 876.1500

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EXB Class 1

Collector, Ostomy

Clearances 101

Regulation 21 CFR 876.5900

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FED Class 2

Endoscopic Access Overtube, Gastroenterology-Urology

Clearances 99

Regulation 21 CFR 876.1500

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FET Class 2

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Clearances 99

Regulation 21 CFR 876.1500

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FAJ Class 2

Cystoscope And Accessories, Flexible/Rigid

Clearances 91

Regulation 21 CFR 876.1500

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KPI Class 2

Stimulator, Electrical, Non-Implantable, For Incontinence

Clearances 88

Regulation 21 CFR 876.5320

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LKY Class 2

Device, External Penile Rigidity

Clearances 87

Regulation 21 CFR 876.5020

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FAP Class 2

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Clearances 85

Regulation 21 CFR 876.1620

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OCX Class 2

Endoscopic Irrigation/Suction System

Clearances 85

Regulation 21 CFR 876.1500

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FBK Class 2

Endoscopic Injection Needle, Gastroenterology-Urology

Clearances 84

Regulation 21 CFR 876.1500

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EZD Class 2

Catheter, Straight

Clearances 81

Regulation 21 CFR 876.5130

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FKX Class 2

System, Peritoneal, Automatic Delivery

Clearances 81

Regulation 21 CFR 876.5630

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FIE Class 2

Needle, Fistula

Clearances 76

Regulation 21 CFR 876.5540

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FJK Class 2

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Clearances 76

Regulation 21 CFR 876.5820

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FDS Class 2

Gastroscope And Accessories, Flexible/Rigid

Clearances 75

Regulation 21 CFR 876.1500

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OCZ Class 2

Endoscopic Grasping/Cutting Instrument, Non-Powered

Clearances 71

Regulation 21 CFR 876.1500

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OCW Class 2

Endoscopic Tissue Approximation Device

Clearances 70

Regulation 21 CFR 876.1500

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ODC Class 2

Endoscope Channel Accessory

Clearances 70

Regulation 21 CFR 876.1500

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FFX Class 2

System, Gastrointestinal Motility (Electrical)

Clearances 69

Regulation 21 CFR 876.1725

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GBM Class 2

Catheter, Urethral

Clearances 65

Regulation 21 CFR 876.5130

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LFJ Class 2

Catheter, Subclavian

Clearances 65

Regulation 21 CFR 876.5540

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KNY Class 2

Accessories, Catheter, G-U

Clearances 62

Regulation 21 CFR 876.5130

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FFK Class 2

Lithotriptor, Electro-Hydraulic

Clearances 61

Regulation 21 CFR 876.4480

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FKQ Class 2

System, Dialysate Delivery, Central Multiple Patient

Clearances 61

Regulation 21 CFR 876.5820

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PKL Class 2

Hemostatic Metal Clip For The Gi Tract

Clearances 61

Regulation 21 CFR 876.4400

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FCM Class 2

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Clearances 60

Regulation 21 CFR 876.5130

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FPD Class 2

Tube, Feeding

Clearances 59

Regulation 21 CFR 876.5980

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FAS Class 2

Electrode, Electrosurgical, Active, Urological

Clearances 57

Regulation 21 CFR 876.4300

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LIF Class 2

Dialyzer Reprocessing System

Clearances 57

Regulation 21 CFR 876.5820

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EYQ Class 1

Garment, Protective, For Incontinence

Clearances 56

Regulation 21 CFR 876.5920

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EZN Class 2

Dilator, Catheter, Ureteral

Clearances 56

Regulation 21 CFR 876.5470

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FEB Class 2

Accessories, Cleaning, For Endoscope

Clearances 56

Regulation 21 CFR 876.1500

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FDI Class 2

Snare, Flexible

Clearances 55

Regulation 21 CFR 876.4300

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OWN Class 2

Confocal Optical Imaging

Clearances 53

Regulation 21 CFR 876.1500

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FFL Class 2

Dislodger, Stone, Basket, Ureteral, Metal

Clearances 52

Regulation 21 CFR 876.4680

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LNS Class 2

Lithotriptor, Extracorporeal Shock-Wave, Urological

Clearances 52

Regulation 21 CFR 876.5990

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FKP Class 2

System, Dialysate Delivery, Single Patient

Clearances 50

Regulation 21 CFR 876.5820

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FFT Class 1

Electrode, Ph, Stomach

Clearances 49

Regulation 21 CFR 876.1400

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FJS Class 2

Catheter, Peritoneal, Long-Term Indwelling

Clearances 48

Regulation 21 CFR 876.5630

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GCT Class 2

Light Source, Endoscope, Xenon Arc

Clearances 47

Regulation 21 CFR 876.1500

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KGE Class 2

Forceps, Biopsy, Electric

Clearances 45

Regulation 21 CFR 876.4300

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KOA Class 1

Surgical Instruments, G-U, Manual (And Accessories)

Clearances 44

Regulation 21 CFR 876.4730

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FDX Class 2

Endoscopic Cytology Brush

Clearances 43

Regulation 21 CFR 876.1500

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ODG Class 2

Endoscopic Ultrasound System, Gastroenterology-Urology

Clearances 43

Regulation 21 CFR 876.1500

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FBN Class 2

Choledochoscope And Accessories, Flexible/Rigid

Clearances 42

Regulation 21 CFR 876.1500

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KDN Class 2

System, Perfusion, Kidney

Clearances 41

Regulation 21 CFR 876.5880

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LYK Class 2

Angioscope

Clearances 41

Regulation 21 CFR 876.1500

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NEZ Class 2

System, Imaging, Gastrointestinal, Wireless, Capsule

Clearances 41

Regulation 21 CFR 876.1300

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KNQ Class 2

Dilator, Esophageal

Clearances 40

Regulation 21 CFR 876.5365

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PIF Class 2

Gastrointestinal Tubes With Enteral Specific Connectors

Clearances 40

Regulation 21 CFR 876.5980

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FCL Class 1

Forceps, Biopsy, Non-Electric

Clearances 39

Regulation 21 CFR 876.1075

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MPA Class 2

Endoilluminator

Clearances 39

Regulation 21 CFR 876.1500

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KPL Class 2

Colonic Irrigation System

Clearances 38

Regulation 21 CFR 876.5220

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LQR Class 2

Dislodger, Stone, Biliary

Clearances 38

Regulation 21 CFR 876.5010

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MPB Class 2

Catheter, Hemodialysis, Non-Implanted

Clearances 38

Regulation 21 CFR 876.5540

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KPN Class 2

Alarm, Conditioned Response Enuresis

Clearances 37

Regulation 21 CFR 876.2040

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FEN Class 2

Device, Cystometric, Hydraulic

Clearances 36

Regulation 21 CFR 876.1620

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FJG Class 2

Dialyzer, Parallel Flow

Clearances 36

Regulation 21 CFR 876.5820

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FDT Class 2

Duodenoscope And Accessories, Flexible/Rigid

Clearances 35

Regulation 21 CFR 876.1500

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FIB Class 2

Protector, Transducer, Dialysis

Clearances 35

Regulation 21 CFR 876.5820

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OCY Class 2

Endoscopic Guidewire, Gastroenterology-Urology

Clearances 35

Regulation 21 CFR 876.1500

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FAE Class 2

Prosthesis, Penile

Clearances 32

Regulation 21 CFR 876.3630

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KOB Class 2

Catheter, Suprapubic (And Accessories)

Clearances 31

Regulation 21 CFR 876.5090

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PNR Class 2

Enteral Syringes With Enteral Specific Connectors

Clearances 31

Regulation 21 CFR 876.5980

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FCE Class 1

Enema Kit

Clearances 30

Regulation 21 CFR 876.5210

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FCW Class 2

Light Source, Fiberoptic, Routine

Clearances 30

Regulation 21 CFR 876.1500

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KLA Class 2

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Clearances 30

Regulation 21 CFR 876.1725

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LJH Class 2

System, Irrigation, Urological

Clearances 29

Regulation 21 CFR 876.5130

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EYB Class 2

Catheter, Ureteral, Gastro-Urology

Clearances 27

Regulation 21 CFR 876.5130

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KOE Class 2

Dilator, Urethral

Clearances 27

Regulation 21 CFR 876.5520

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OCT Class 2

Anti Fog Solution And Accessories, Endoscopy

Clearances 27

Regulation 21 CFR 876.1500

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FER Class 2

Anoscope And Accessories

Clearances 26

Regulation 21 CFR 876.1500

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FFS Class 2

Image, Illumination, Fiberoptic, For Endoscope

Clearances 26

Regulation 21 CFR 876.1500

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GCA Class 2

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Clearances 26

Regulation 21 CFR 876.5010

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KGC Class 2

Tube, Gastro-Enterostomy

Clearances 26

Regulation 21 CFR 876.5980

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FAM Class 2

Sigmoidoscope And Accessories, Flexible/Rigid

Clearances 24

Regulation 21 CFR 876.1500

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FJL Class 2

Resectoscope

Clearances 24

Regulation 21 CFR 876.1500

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FCX Class 2

Insufflator, Automatic Carbon-Dioxide For Endoscope

Clearances 23

Regulation 21 CFR 876.1500

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FIQ Class 2

Cannula, A-V Shunt

Clearances 23

Regulation 21 CFR 876.5540

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KDH Class 2

Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Clearances 23

Regulation 21 CFR 876.5980

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EXJ Class 1

Device, Incontinence, Urosheath Type, Sterile

Clearances 22

Regulation 21 CFR 876.5250

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NLM Class 2

Laparoscope, General & Plastic Surgery, Reprocessed

Clearances 22

Regulation 21 CFR 876.1500

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QNP Class 2

Gastrointesinal Lesion Software Detection System

Clearances 22

Regulation 21 CFR 876.1520

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FHN Class 2

Ligator, Hemorrhoidal

Clearances 21

Regulation 21 CFR 876.4400

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FCO Class 1

Box, Battery, Rechargeable

Clearances 20

Regulation 21 CFR 876.1500

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FDA Class 2

Enteroscope And Accessories

Clearances 19

Regulation 21 CFR 876.1500

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FGO Class 2

Dislodger, Stone, Flexible

Clearances 19

Regulation 21 CFR 876.4680

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FKT Class 2

System, Dialysate Delivery, Sorbent Regenerated

Clearances 19

Regulation 21 CFR 876.5600

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KDL Class 2

Set, Perfusion, Kidney, Disposable

Clearances 19

Regulation 21 CFR 876.5880

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KPM Class 2

Shunt, Peritoneal

Clearances 19

Regulation 21 CFR 876.5955

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FAQ Class 1

Bag, Urine Collection, Leg, For External Use, Sterile

Clearances 18

Regulation 21 CFR 876.5250

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FBO Class 2

Cystourethroscope

Clearances 18

Regulation 21 CFR 876.1500

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FEQ Class 2

Pump, Air, Non-Manual, For Endoscope

Clearances 18

Regulation 21 CFR 876.1500

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GCM Class 2

Endoscope, Rigid

Clearances 18

Regulation 21 CFR 876.1500

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MQS Class 2

System, Hemodialysis, Access Recirculation Monitoring

Clearances 18

Regulation 21 CFR 876.5820

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ODA Class 2

Endoscopic Central Control Unit

Clearances 18

Regulation 21 CFR 876.1500

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ODD Class 2

Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Clearances 18

Regulation 21 CFR 876.1500

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FFG Class 2

Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

Clearances 17

Regulation 21 CFR 876.1800

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FIN Class 2

Tank, Holding, Dialysis

Clearances 16

Regulation 21 CFR 876.5820

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FKO Class 2

Catheter, Peritoneal Dialysis, Single Use

Clearances 16

Regulation 21 CFR 876.5630

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LFK Class 2

Catheter, Femoral

Clearances 16

Regulation 21 CFR 876.5540

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EXY Class 2

Uroflowmeter

Clearances 15

Regulation 21 CFR 876.1800

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EYN Class 2

Tray, Irrigation, Sterile

Clearances 15

Regulation 21 CFR 876.5980

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FHO Class 2

Pneumoperitoneum Needle

Clearances 15

Regulation 21 CFR 876.1500

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MND Class 2

Ligator, Esophageal

Clearances 15

Regulation 21 CFR 876.4400

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ODE Class 2

Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Clearances 15

Regulation 21 CFR 876.1500

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PNG Class 2

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Clearances 15

Regulation 21 CFR 876.5630

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EYZ Class 1

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Clearances 14

Regulation 21 CFR 876.5250

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GCI Class 2

Laryngoscope, Endoscope

Clearances 14

Regulation 21 CFR 876.1500

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KQT Class 2

Evacuator, Gastro-Urology

Clearances 14

Regulation 21 CFR 876.4370

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FCK Class 2

Instrument, Biopsy, Suction

Clearances 13

Regulation 21 CFR 876.1075

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FEG Class 2

Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Clearances 13

Regulation 21 CFR 876.5980

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FEO Class 2

Lithotriptor, Ultrasonic

Clearances 13

Regulation 21 CFR 876.4480

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GCP Class 2

Endoscope, Ac-Powered And Accessories

Clearances 13

Regulation 21 CFR 876.1500

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KPF Class 2

System, Dialysate Delivery, Semi-Automatic, Peritoneal

Clearances 13

Regulation 21 CFR 876.5630

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BSS Class 2

Tube, Nasogastric

Clearances 12

Regulation 21 CFR 876.5980

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EXD Class 2

Irrigator, Ostomy

Clearances 12

Regulation 21 CFR 876.5895

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FHS Class 2

Dialyzer, Single Coil

Clearances 12

Regulation 21 CFR 876.5820

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FIZ Class 2

Meter, Conductivity, Non-Remote

Clearances 12

Regulation 21 CFR 876.5820

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MSB Class 2

System And Accessories, Isolated Heart, Transport And Preservation

Clearances 12

Regulation 21 CFR 876.5880

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MSY Class 2

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Clearances 12

Regulation 21 CFR 876.5665

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NVE Class 2

Washer, Cleaner, Automated, Endoscope

Clearances 12

Regulation 21 CFR 876.1500

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ODF Class 2

Mini Endoscope, Gastroenterology-Urology

Clearances 12

Regulation 21 CFR 876.1500

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FDC Class 2

Resectoscope, Working Element

Clearances 11

Regulation 21 CFR 876.1500

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FHA Class 1

Clamp, Penile

Clearances 11

Regulation 21 CFR 876.5160

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FKR Class 2

Subsystem, Proportioning

Clearances 11

Regulation 21 CFR 876.5820

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LQC Class 2

Lithotriptor, Biliary Mechanical

Clearances 11

Regulation 21 CFR 876.4500

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NFK Class 2

Kit, Repair, Catheter, Hemodialysis

Clearances 11

Regulation 21 CFR 876.5540

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NHV Class 2

System, Water Purification, General Medical Use

Clearances 11

Regulation 21 CFR 876.5665

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NZA Class 2

Accessories, Germicide, Cleaning, For Endoscopes

Clearances 11

Regulation 21 CFR 876.1500

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OTJ Class 2

Laparoscopic Single Port Access Device

Clearances 11

Regulation 21 CFR 876.1500

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PLP Class 2

High Intensity Ultrasound System For Prostate Tissue Ablation

Clearances 11

Regulation 21 CFR 876.4340

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FCN Class 2

Urinary Drainage Collection Kit, For Indwelling Catheter

Clearances 10

Regulation 21 CFR 876.5250

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FGA Class 2

Kit, Nephroscope

Clearances 10

Regulation 21 CFR 876.1500

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FLD Class 2

Apparatus, Hemoperfusion, Sorbent

Clearances 10

Regulation 21 CFR 876.5870

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KNZ Class 2

Accessories, A-V Shunt

Clearances 10

Regulation 21 CFR 876.5540

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MJC Class 2

Catheter, Urological (Antimicrobial) And Accessories

Clearances 10

Regulation 21 CFR 876.5130

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OCV Class 2

Endoscope Holder

Clearances 10

Regulation 21 CFR 876.1500

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PEW Class 2

Implantable Transprostatic Tissue Retractor System

Clearances 10

Regulation 21 CFR 876.5530

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EXF Class 2

Bag, Bile Collecting

Clearances 9

Regulation 21 CFR 876.5010

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EXR Class 2

Urinometer, Mechanical

Clearances 9

Regulation 21 CFR 876.1800

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FBM Class 1

Cannula And Trocar, Suprapubic, Non-Disposable

Clearances 9

Regulation 21 CFR 876.5090

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FBQ Class 2

Trocar, Gastro-Urology

Clearances 9

Regulation 21 CFR 876.5090

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FCS Class 2

Light, Catheter, Fiberoptic, Glass, Ureteral

Clearances 9

Regulation 21 CFR 876.4020

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GCS Class 2

Endoscope, Battery-Powered And Accessories

Clearances 9

Regulation 21 CFR 876.1500

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NIE Class 2

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Clearances 9

Regulation 21 CFR 876.5540

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PLL Class 2

Submucosal Injection Agent

Clearances 9

Regulation 21 CFR 876.1500

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EXQ Class 2

Cystometer, Electrical Recording

Clearances 8

Regulation 21 CFR 876.1620

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FIL Class 2

System, Dialysate Delivery, Single Pass

Clearances 8

Regulation 21 CFR 876.5820

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FKH Class 2

Solution-Test Standard-Conductivity, Dialysis

Clearances 8

Regulation 21 CFR 876.5820

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KQS Class 1

Table, Cystometric, Non-Electric And Accessories

Clearances 8

Regulation 21 CFR 876.4890

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MSF Class 2

Hemodialyzer, Re-Use, High Flux

Clearances 8

Regulation 21 CFR 876.5860

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MYE Class 2

System, Electrogastrography (Egg)

Clearances 8

Regulation 21 CFR 876.1735

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NDS Class 2

Media, Culture, Ex Vivo, Tissue And Cell

Clearances 8

Regulation 21 CFR 876.5885

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NWB Class 2

Endoscope, Accessories, Narrow Band Spectrum

Clearances 8

Regulation 21 CFR 876.1500

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QSM Class 2

System, Surgical, Computer Controlled Instrument, Remanufactured

Clearances 8

Regulation 21 CFR 876.1500

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EXI Class 1

Device, Paste-On For Incontinence, Sterile

Clearances 7

Regulation 21 CFR 876.5250

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EZC Class 2

Catheter, Coude

Clearances 7

Regulation 21 CFR 876.5130

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FAT Class 2

Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

Clearances 7

Regulation 21 CFR 876.5365

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FGM Class 1

Probe And Director, Gastro-Urology

Clearances 7

Regulation 21 CFR 876.4730

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FHQ Class 1

Holder, Needle, Gastroenterologic

Clearances 7

Regulation 21 CFR 876.4730

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FIR Class 2

Pump, Blood, Extra-Luminal

Clearances 7

Regulation 21 CFR 876.5820

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GDB Class 2

Endoscope, Fiber Optic

Clearances 7

Regulation 21 CFR 876.1500

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MNG Class 1

External Urethral Occluder, Urinary Incontinence-Control, Female

Clearances 7

Regulation 21 CFR 876.5160

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MSE Class 2

Hemodialyzer, Re-Use, Low Flux

Clearances 7

Regulation 21 CFR 876.5820

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NAM Class 2

Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

Clearances 7

Regulation 21 CFR 876.5310

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NSI Class 2

System, Imaging, Esophageal, Wireless, Capsule

Clearances 7

Regulation 21 CFR 876.1300

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NTN Class 2

Led Light Source

Clearances 7

Regulation 21 CFR 876.1500

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PEA Class 2

Endoscope, Accessories, Image Post-Processing For Color Enhancement

Clearances 7

Regulation 21 CFR 876.1500

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PLQ Class 2

Enzyme Packed Cartridge

Clearances 7

Regulation 21 CFR 876.5985

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EZQ Class 1

Pouch, Colostomy

Clearances 6

Regulation 21 CFR 876.5900

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EZR Class 1

Cement, Stomal Appliance, Ostomy

Clearances 6

Regulation 21 CFR 876.5900

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FCF Class 2

Instrument, Biopsy, Mechanical, Gastrointestinal

Clearances 6

Regulation 21 CFR 876.1075

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FGD Class 2

Catheter, Retention, Barium Enema With Bag

Clearances 6

Regulation 21 CFR 876.5980

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FHX Class 2

Jelly, Lubricating, For Transurethral Surgical Instrument

Clearances 6

Regulation 21 CFR 876.1500

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FIF Class 2

Set, Dialysis, Single Needle With Uni-Directional Pump

Clearances 6

Regulation 21 CFR 876.5820

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FKG Class 1

Tray, Start/Stop (Including Contents), Dialysis

Clearances 6

Regulation 21 CFR 876.5820

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FKK Class 1

Clamp, Line

Clearances 6

Regulation 21 CFR 876.4730

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FLB Class 2

Meter, Conductivity, Induction, Remote Type

Clearances 6

Regulation 21 CFR 876.5820

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MLW Class 2

Warmer, Peritoneal Dialysate

Clearances 6

Regulation 21 CFR 876.5630

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MNK Class 1

Endoscopic Bite Block

Clearances 6

Regulation 21 CFR 876.1500

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MNV Class 2

Strip, Dialysate Ph Indicator

Clearances 6

Regulation 21 CFR 876.5820

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OCU Class 2

Endoscopic Storage Cover

Clearances 6

Regulation 21 CFR 876.1500

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PCU Class 2

Pancreatic Stent, Covered, Metallic, Removable

Clearances 6

Regulation 21 CFR 876.5015

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EYC Class 2

Catheter, Upper Urinary Tract

Clearances 5

Regulation 21 CFR 876.5130

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EZO Class 2

Urethrotome

Clearances 5

Regulation 21 CFR 876.4770

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FCI Class 2

Punch, Biopsy

Clearances 5

Regulation 21 CFR 876.1075

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FEW Class 2

Catheter, Malecot

Clearances 5

Regulation 21 CFR 876.5090

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FFN Class 1

Clamp, Non-Electrical

Clearances 5

Regulation 21 CFR 876.4730

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FFO Class 1

Retractor, Self-Retaining

Clearances 5

Regulation 21 CFR 876.4730

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FFP Class 1

Dilator, Rectal

Clearances 5

Regulation 21 CFR 876.5450

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FIH Class 2

Pump, Infusion Or Syringe, Extra-Luminal

Clearances 5

Regulation 21 CFR 876.5820

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FII Class 2

System, Dialysate Delivery, Sealed

Clearances 5

Regulation 21 CFR 876.5860

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FJF Class 2

Detector, Air Bubble

Clearances 5

Regulation 21 CFR 876.5820

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FJT Class 2

Intracatheter, Dialysis

Clearances 5

Regulation 21 CFR 876.5820

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FKJ Class 2

Filter, Blood, Dialysis

Clearances 5

Regulation 21 CFR 876.5820

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GCQ Class 2

Endoscope, Flexible

Clearances 5

Regulation 21 CFR 876.1500

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LBW Class 2

Set, Dialysis, Single Needle (Co-Axial Flow)

Clearances 5

Regulation 21 CFR 876.5540

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NYV Class 2

Gastrointestinal Motility System, Capsule

Clearances 5

Regulation 21 CFR 876.1725

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ODB Class 2

Endoscopic Contamination Prevention Sheath

Clearances 5

Regulation 21 CFR 876.1500

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PIO Class 2

Enteral Specific Transition Connectors

Clearances 5

Regulation 21 CFR 876.5980

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QHH Class 2

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Clearances 5

Regulation 21 CFR 876.5340

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QKZ Class 2

Magnetically Maneuvered Capsule Endoscopy System

Clearances 5

Regulation 21 CFR 876.1310

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EYT Class 1

Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile

Clearances 4

Regulation 21 CFR 876.5250

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FAH Class 2

Dilator, Urethral, Mechanical

Clearances 4

Regulation 21 CFR 876.5520

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FBP Class 2

Telescope, Rigid, Endoscopic

Clearances 4

Regulation 21 CFR 876.1500

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FDE Class 2

Laparoscopy Kit

Clearances 4

Regulation 21 CFR 876.1500

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FEM Class 1

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Clearances 4

Regulation 21 CFR 876.1500

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FGS Class 2

Carrier, Sponge, Endoscopic

Clearances 4

Regulation 21 CFR 876.1500

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FIG Class 2

Clamp, Tubing, Blood, Automatic

Clearances 4

Regulation 21 CFR 876.5820

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FJD Class 2

Detector, Leak, Blood

Clearances 4

Regulation 21 CFR 876.5820

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FJH Class 2

Dialyzer, Disposable

Clearances 4

Regulation 21 CFR 876.5830

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FKN Class 2

Adaptor, Shunt

Clearances 4

Regulation 21 CFR 876.5540

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FKY Class 2

Connector, Tubing, Dialysate

Clearances 4

Regulation 21 CFR 876.5820

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FLC Class 2

Station, Dialysis Control, Negative Pressure Type

Clearances 4

Regulation 21 CFR 876.5820

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FOC Class 2

Bag, Urine Collection, Newborn

Clearances 4

Regulation 21 CFR 876.5250

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GCL Class 2

Esophagoscope, General & Plastic Surgery

Clearances 4

Regulation 21 CFR 876.1500

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KXM Class 2

System Accessories, Extracorporeal

Clearances 4

Regulation 21 CFR 876.5820

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MMZ Class 2

Table, Cystometric, Electric

Clearances 4

Regulation 21 CFR 876.4890

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MNL Class 1

Accessories, Cleaning Brushes, For Endoscope

Clearances 4

Regulation 21 CFR 876.1500

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NLU Class 2

Forceps, Biopsy, Electric, Reprocessed

Clearances 4

Regulation 21 CFR 876.4300

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NQJ Class 2

Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Clearances 4

Regulation 21 CFR 876.5540

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ODX Class 2

Autonomous Extracorporeal Blood Leak Detector/Alarm

Clearances 4

Regulation 21 CFR 876.5820

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ONW Class 2

Hemodialysis System For Home Use

Clearances 4

Regulation 21 CFR 876.5860

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QAJ Class 2

Cutaneous Electrode Stimulator For Urinary Incontinence

Clearances 4

Regulation 21 CFR 876.5330

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QZB Class 2

Software Controlled Endoscope And Instrument Holder

Clearances 4

Regulation 21 CFR 876.1500

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EXE Class 1

Protector, Ostomy

Clearances 3

Regulation 21 CFR 876.5900

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EZB Class 1

Stylet For Catheter, Gastro-Urology

Clearances 3

Regulation 21 CFR 876.5130

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EZK Class 2

Catheter, Retention Type

Clearances 3

Regulation 21 CFR 876.5980

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FCC Class 2

Endoscopic Magnetic Retriever

Clearances 3

Regulation 21 CFR 876.1500

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FCR Class 2

Light Source, Photographic, Fiberoptic

Clearances 3

Regulation 21 CFR 876.1500

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FCY Class 1

Bulb, Inflation, For Endoscope

Clearances 3

Regulation 21 CFR 876.1500

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FEC Class 2

Obturator, For Endoscope

Clearances 3

Regulation 21 CFR 876.1500

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FEH Class 2

Electrode, Flexible Suction Coagulator

Clearances 3

Regulation 21 CFR 876.4300

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FFA Class 2

Tube, Drainage, Suprapubic

Clearances 3

Regulation 21 CFR 876.5090

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FFH Class 2

Collector, Urine, Pediatric, For Indwelling Catheter

Clearances 3

Regulation 21 CFR 876.5250

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FFZ Class 2

Cord, Electric, For Endoscope

Clearances 3

Regulation 21 CFR 876.1500

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FGC Class 2

Urethroscope

Clearances 3

Regulation 21 CFR 876.1500

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FGI Class 2

Catheter, Urethrographic, Male

Clearances 3

Regulation 21 CFR 876.5130

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FHF Class 2

System, Evacuator, Fluid

Clearances 3

Regulation 21 CFR 876.4370

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FID Class 2

Tubing, Dialysate

Clearances 3

Regulation 21 CFR 876.5820

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FJB Class 2

Detector, Dialysate Level

Clearances 3

Regulation 21 CFR 876.5820

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FJQ Class 1

Connector, Shunt

Clearances 3

Regulation 21 CFR 876.5540

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FJZ Class 2

Declotting Tray, Kit (Including Contents)

Clearances 3

Regulation 21 CFR 876.5820

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FKA Class 2

Dilator, Vessel

Clearances 3

Regulation 21 CFR 876.5540

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FKI Class 2

Set, Dialyzer Holder

Clearances 3

Regulation 21 CFR 876.5820

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FKW Class 2

Tip, Vessel

Clearances 3

Regulation 21 CFR 876.5540

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FON Class 1

Bag, Drainage, With Adhesive, Ostomy

Clearances 3

Regulation 21 CFR 876.5900

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FRQ Class 2

Tube, Levine

Clearances 3

Regulation 21 CFR 876.5980

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GBT Class 2

Catheter, Rectal

Clearances 3

Regulation 21 CFR 876.5980

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GCO Class 2

Endoscope, Mirror

Clearances 3

Regulation 21 CFR 876.1500

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KDK Class 2

Container, Transport, Kidney

Clearances 3

Regulation 21 CFR 876.5880

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KPP Class 2

Peritoneal Dialysate Filter

Clearances 3

Regulation 21 CFR 876.5630

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NON Class 1

Forceps, Biopsy, Non-Electric, Reprocessed

Clearances 3

Regulation 21 CFR 876.1075

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NOY Class 2

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Clearances 3

Regulation 21 CFR 876.5550

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NWU Class 2

Endoscope Introducer Kit

Clearances 3

Regulation 21 CFR 876.1500

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PID Class 2

Esophageal Dilator Balloon With Or Without Electrode Sensors

Clearances 3

Regulation 21 CFR 876.5980

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QKA Class 2

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Clearances 3

Regulation 21 CFR 876.5510

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QRC Class 2

Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

Clearances 3

Regulation 21 CFR 876.5026

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QXM Class 2

Implanted Tibial Electrical Urinary Continence Device

Clearances 3

Regulation 21 CFR 876.5305

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EZP Class 2

Rod, Colostomy

Clearances 2

Regulation 21 CFR 876.4270

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FAK Class 2

Panendoscope (Gastroduodenoscope)

Clearances 2

Regulation 21 CFR 876.1500

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FAN Class 2

Sigmoidoscope, Rigid, Electrical

Clearances 2

Regulation 21 CFR 876.1500

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FAX Class 1

Bougie, Urological

Clearances 2

Regulation 21 CFR 876.5520

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FCD Class 1

Barium Enema Kit

Clearances 2

Regulation 21 CFR 876.5210

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FCH Class 1

Tray, Biopsy, Without Biopsy Instruments

Clearances 2

Regulation 21 CFR 876.4730

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FCP Class 1

Box, Battery, Pocket

Clearances 2

Regulation 21 CFR 876.1500

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FDG Class 1

Retractor, Fiberoptic

Clearances 2

Regulation 21 CFR 876.4530

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FDZ Class 1

Attachment, Eyepiece, For Insertion Of Prescription Lens

Clearances 2

Regulation 21 CFR 876.1500

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FEA Class 1

Attachment, Teaching, For Endoscope

Clearances 2

Regulation 21 CFR 876.1500

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FEI Class 1

Instrument, Special Lens, For Endoscope

Clearances 2

Regulation 21 CFR 876.1500

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FES Class 2

Recorder, External, Pressure, Amplifier & Transducer

Clearances 2

Regulation 21 CFR 876.1725

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FEX Class 1

Instrument, Catheter, Punch

Clearances 2

Regulation 21 CFR 876.5090

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FFD Class 1

Evacuator, Bladder, Manually Operated

Clearances 2

Regulation 21 CFR 876.4370

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FFY Class 1

Adaptor, Bulbs, Miscellaneous, For Endoscope

Clearances 2

Regulation 21 CFR 876.1500

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FHP Class 2

Needle, Pneumoperitoneum, Simple

Clearances 2

Regulation 21 CFR 876.1500

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FKB Class 2

Connector, Blood Tubing, Infusion T

Clearances 2

Regulation 21 CFR 876.5820

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FLA Class 2

Monitor, Temperature, Dialysis

Clearances 2

Regulation 21 CFR 876.5820

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FTI Class 2

Lamp, Endoscope, Incandescent

Clearances 2

Regulation 21 CFR 876.1500

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FTQ Class 2

Prosthesis, Penis, Rigid Rod

Clearances 2

Regulation 21 CFR 876.3630

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GCF Class 2

Proctoscope

Clearances 2

Regulation 21 CFR 876.1500

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GDS Class 1

Bag, Stomal

Clearances 2

Regulation 21 CFR 876.5900

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KGD Class 2

Scissors For Cystoscope

Clearances 2

Regulation 21 CFR 876.1500

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LLB Class 2

System, Blood, Extracorporeal And Accessories

Clearances 2

Regulation 21 CFR 876.5820

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NBG Class 2

Marker, Colon

Clearances 2

Regulation 21 CFR 876.1500

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NEQ Class 2

Device, Telemedicine, Robotic

Clearances 2

Regulation 21 CFR 876.1500

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NII Class 2

Disinfectant, Dialysate Delivery System

Clearances 2

Regulation 21 CFR 876.5860

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NYU Class 2

Catheter, Hemodialysis, Implanted, Coated

Clearances 2

Regulation 21 CFR 876.5540

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PBP Class 2

Rectal Insert

Clearances 2

Regulation 21 CFR 876.5980

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PCV Class 2

Endoscopic Leak Tester

Clearances 2

Regulation 21 CFR 876.1500

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PEH Class 2

Hemodialysis Catheter Luer End Cap

Clearances 2

Regulation 21 CFR 876.5540

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QFQ Class 2

Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Clearances 2

Regulation 21 CFR 876.5982

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QIS Class 2

Esophageal, Mucosal, Electrical Characterization

Clearances 2

Regulation 21 CFR 876.1450

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QJN Class 2

Laparoscopic Accessories, Esophageal Sizing

Clearances 2

Regulation 21 CFR 876.5360

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QMY Class 2

Computerized Behavioral Therapy Device For Treating Symptoms

Clearances 2

Regulation 21 CFR 876.5960

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QTN Class 2

Orally Ingested Transient Device For Constipation

Clearances 2

Regulation 21 CFR 876.5940

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QZF Class 2

Gastrointestinal Capsule Endoscopy Analysis Software Device

Clearances 2

Regulation 21 CFR 876.1540

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SFE Class 2

Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation

Clearances 2

Regulation 21 CFR 876.1500

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EXA Class 1

Selector, Size, Ostomy

Clearances 1

Regulation 21 CFR 876.5900

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EXN Class 1

Support, Hernia

Clearances 1

Regulation 21 CFR 876.5970

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EXW Class 2

Pill, Radio

Clearances 1

Regulation 21 CFR 876.1725

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EYK Class 1

Connector, Ureteral Catheter

Clearances 1

Regulation 21 CFR 876.5130

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EZS Class 1

Appliance, Colostomy, Disposable

Clearances 1

Regulation 21 CFR 876.5900

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FAL Class 2

Panendoscope (Urethroscope)

Clearances 1

Regulation 21 CFR 876.1500

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FBS Class 1

Sound, Metal, Interconnected

Clearances 1

Regulation 21 CFR 876.4590

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FBW Class 1

Filiform And Filiform Follower

Clearances 1

Regulation 21 CFR 876.5520

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FBX Class 1

Sound, Urethral, Metal Or Plastic

Clearances 1

Regulation 21 CFR 876.5520

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FCQ Class 2

Light Source, Incandescent, Diagnostic

Clearances 1

Regulation 21 CFR 876.1500

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FDP Class 2

Apparatus, Pneumoperitoneum, Automatic

Clearances 1

Regulation 21 CFR 876.1500

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FEF Class 2

Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

Clearances 1

Regulation 21 CFR 876.5980

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FEJ Class 1

Attachment, Binocular, For Endoscope

Clearances 1

Regulation 21 CFR 876.1500

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FEZ Class 2

Catheter And Tube, Suprapubic

Clearances 1

Regulation 21 CFR 876.5090

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FFE Class 2

System, Water Jet Catheter, Renal

Clearances 1

Regulation 21 CFR 876.4650

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FFF Class 1

Cover, Biopsy Forceps

Clearances 1

Regulation 21 CFR 876.1075

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FFI Class 2

System, Alarm, Electrosurgical

Clearances 1

Regulation 21 CFR 876.4300

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FFQ Class 1

Speculum, Rectal

Clearances 1

Regulation 21 CFR 876.4730

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FGF Class 2

Catheter, Ureteral Disposable (X-Ray)

Clearances 1

Regulation 21 CFR 876.5130

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FGH Class 2

Catheter, Double Lumen Female Urethrographic

Clearances 1

Regulation 21 CFR 876.5130

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FGK Class 2

Tripsor, Stone, Bladder

Clearances 1

Regulation 21 CFR 876.4500

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FHT Class 2

Set, Gavage, Infant, Sterile

Clearances 1

Regulation 21 CFR 876.5980

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FIJ Class 2

System, Dialysate Delivery, Recirculating, Single Pass

Clearances 1

Regulation 21 CFR 876.5820

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FIW Class 2

Alarm, Pillow Pressure

Clearances 1

Regulation 21 CFR 876.5820

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FJC Class 2

Detector, Blood Level

Clearances 1

Regulation 21 CFR 876.5820

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FKC Class 1

Clamp, Cannula

Clearances 1

Regulation 21 CFR 876.5540

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FKD Class 2

Canister, Coil

Clearances 1

Regulation 21 CFR 876.5820

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FKL Class 2

Insert, Pump, Blood

Clearances 1

Regulation 21 CFR 876.5820

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GCW Class 2

Transformer, Endoscope

Clearances 1

Regulation 21 CFR 876.1500

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KDM Class 2

Sigmoidoscope, Rigid, Non-Electrical

Clearances 1

Regulation 21 CFR 876.1500

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KDO Class 2

Rongeur, Cystoscopic, Hot

Clearances 1

Regulation 21 CFR 876.1500

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KNR Class 2

Adapter, A-V Shunt Or Fistula

Clearances 1

Regulation 21 CFR 876.5540

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KPH Class 1

Catheter, Rectal For Continent Ileostomy

Clearances 1

Regulation 21 CFR 876.5030

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KQQ Class 2

Tubing, Dialysate (And Connector)

Clearances 1

Regulation 21 CFR 876.5820

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KYH Class 2

Endoscope, Ophthalmic

Clearances 1

Regulation 21 CFR 876.1500

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LEY Class 2

Set, Oral Administration

Clearances 1

Regulation 21 CFR 876.5980

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LRI Class 2

Ph Meter For Dialysis Hydrogen Ion Concentration

Clearances 1

Regulation 21 CFR 876.5820

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MFJ Class 2

Device, Endoscopic Suturing

Clearances 1

Regulation 21 CFR 876.1500

View devices →

NGU Class 2

Balloon, Liver Tamponade

Clearances 1

Regulation 21 CFR 876.5980

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NLR Class 2

Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed

Clearances 1

Regulation 21 CFR 876.4300

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NLW Class 2

Electrode, Electrosurgical, Active, Urological, Reprocessed

Clearances 1

Regulation 21 CFR 876.4300

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NML Class 2

Catheter, Biliary, Reprocessed

Clearances 1

Regulation 21 CFR 876.5010

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NTZ Class 2

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

Clearances 1

Regulation 21 CFR 876.5820

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NWO Class 2

Kit, Catheter, Urinary (Exludes Hiv Testing)

Clearances 1

Regulation 21 CFR 876.5130

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NWS Class 2

Kit, Choledochoscope, Flexible And Rigid

Clearances 1

Regulation 21 CFR 876.1500

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NZU Class 1

Collector, Urine, Powered, Non Indwelling Catheter

Clearances 1

Regulation 21 CFR 876.5250

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OCS Class 2

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Clearances 1

Regulation 21 CFR 876.1500

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ONJ Class 2

Dissolvable Gel For Preventing Ureteral Stone Migration

Clearances 1

Regulation 21 CFR 876.4680

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ONY Class 2

Oral Removable Retainer For Weight Management

Clearances 1

Regulation 21 CFR 876.5981

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OOW Class 1

Applicator For Rectal Suppository

Clearances 1

Regulation 21 CFR 876.4730

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PFH Class 2

Venous Window Needle Guide

Clearances 1

Regulation 21 CFR 876.5540

View devices →

PGD Class 2

Colon Capsule Imaging System

Clearances 1

Regulation 21 CFR 876.1330

View devices →

PIE Class 2

Esophageal Dilator With Balloon And Electrode Sensors

Clearances 1

Regulation 21 CFR 876.5980

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PLI Class 2

Gastrointestional Tube Holder

Clearances 1

Regulation 21 CFR 876.5980

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PSX Class 2

Chlorine Meter

Clearances 1

Regulation 21 CFR 876.5665

View devices →

PUP Class 2

Endoscope Maintenance System

Clearances 1

Regulation 21 CFR 876.1500

View devices →

QAX Class 2

Hemodialyzer With Expanded Solute Removal Profile

Clearances 1

Regulation 21 CFR 876.5862

View devices →

QEC Class 2

Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree

Clearances 1

Regulation 21 CFR 876.4300

View devices →

QEJ Class 2

Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

Clearances 1

Regulation 21 CFR 876.4100

View devices →

QGG Class 2

Esophageal Sheath With Distal Balloon Anchor

Clearances 1

Regulation 21 CFR 876.1510

View devices →

QGY Class 2

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

Clearances 1

Regulation 21 CFR 876.1500

View devices →

QNA Class 2

Ultrasonic Urinary Stone Propulsion Device

Clearances 1

Regulation 21 CFR 876.4690

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QSW Class 2

Endoscopic Traction Device

Clearances 1

Regulation 21 CFR 876.4410

View devices →

QTD Class 2

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

Clearances 1

Regulation 21 CFR 876.5983

View devices →

SHU Class 2

Appendiceal Scope And Accessories, Flexible

Clearances 1

Regulation 21 CFR 876.1500

View devices →

EXG Class 1

Bag, Urine Collecting, Ureterostomy

Clearances 0

Regulation 21 CFR 876.5900

View devices →

EXH Class 1

Bag, Urinary, Ileostomy

Clearances 0

Regulation 21 CFR 876.5900

View devices →

EXM Class 1

Truss, Umbilical

Clearances 0

Regulation 21 CFR 876.5970

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EXS Class 2

Urinometer, Electrical

Clearances 0

Regulation 21 CFR 876.1800

View devices →

EXX Class 1

Probe, Rectal, Non-Powered

Clearances 0

Regulation 21 CFR 876.4730

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EXZ Class 1

Equipment, Photographic, For Physiologic Function Monitor

Clearances 0

Regulation 21 CFR 876.1500

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EYA Class 1

Stylet, Ureteral

Clearances 0

Regulation 21 CFR 876.5130

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EYD Class 1

Stirrups

Clearances 0

Regulation 21 CFR 876.4890

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EYH Class 1

Table, Cysto, Non-Electrical

Clearances 0

Regulation 21 CFR 876.4890

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EYI Class 1

Adaptor, Ureteral Catheter

Clearances 0

Regulation 21 CFR 876.5130

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EYJ Class 1

Holder, Ureteral Catheter

Clearances 0

Regulation 21 CFR 876.5130

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EYS Class 1

Ribdam

Clearances 0

Regulation 21 CFR 876.4560

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EZM Class 2

Dilator, Esophageal (Metal Olive) Gastro-Urology

Clearances 0

Regulation 21 CFR 876.5365

View devices →

EZT Class 3

Pacemaker, Bladder

Clearances 0

Regulation 21 CFR 876.5270

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EZW Class 3

Stimulator, Electrical, Implantable, For Incontinence

Clearances 0

Regulation 21 CFR 876.5270

View devices →

EZY Class 3

Device, Incontinence, Mechanical/Hydraulic

Clearances 0

Regulation 21 CFR 876.5280

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FAF Class 3

Prosthesis, Testicular

Clearances 0

Regulation 21 CFR 876.3750

View devices →

FAR Class 2

Unit, Electrosurgical

Clearances 0

Regulation 21 CFR 876.4300

View devices →

FBI Class 2

Rongeur, Cystoscopic

Clearances 0

Regulation 21 CFR 876.1500

View devices →

FBJ Class 2

Cord, Electric For Transurethral Surgical Instrument

Clearances 0

Regulation 21 CFR 876.4300

View devices →

FBR Class 1

Urethrometer

Clearances 0

Regulation 21 CFR 876.5520

View devices →

FCB Class 2

Bag, Hemostatic

Clearances 0

Regulation 21 CFR 876.5980

View devices →

FCZ Class 1

Tube, Smoke Removal, Endoscopic

Clearances 0

Regulation 21 CFR 876.1500

View devices →

FDB Class 2

Plate, Patient

Clearances 0

Regulation 21 CFR 876.4300

View devices →

FDJ Class 2

Snare, Rigid Self-Opening

Clearances 0

Regulation 21 CFR 876.4300

View devices →

FDL Class 2

Wristlet, Patient Return

Clearances 0

Regulation 21 CFR 876.4300

View devices →

FDR Class 2

Sphyncteroscope

Clearances 0

Regulation 21 CFR 876.1500

View devices →

FDW Class 2

Esophagoscope, Rigid, Gastro-Urology

Clearances 0

Regulation 21 CFR 876.1500

View devices →

FDY Class 1

Device, Measuring, For Panendoscope

Clearances 0

Regulation 21 CFR 876.1500

View devices →

FFR Class 1

Device, Locking, For Intestinal Clamp

Clearances 0

Regulation 21 CFR 876.4730

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FFW Class 2

String And Tubes, Gastrointestinal, To Locate Internal Bleeding

Clearances 0

Regulation 21 CFR 876.5980

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FGN Class 1

Retractor, Non-Self-Retaining

Clearances 0

Regulation 21 CFR 876.4730

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FGW Class 2

Clamp, Electrical

Clearances 0

Regulation 21 CFR 876.4300

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FGX Class 1

Snare, Non-Electrical

Clearances 0

Regulation 21 CFR 876.4730

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FHB Class 1

Hook, Gastro-Urology

Clearances 0

Regulation 21 CFR 876.4730

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FHC Class 2

Adaptor To The Cord, For Transurethral Surgical Instrument

Clearances 0

Regulation 21 CFR 876.4300

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FHH Class 1

Crusher, Spur, Colostomy

Clearances 0

Regulation 21 CFR 876.4730

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FHI Class 1

Ring, Laparotomy

Clearances 0

Regulation 21 CFR 876.4730

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FHK Class 1

Spreader, Bladder Neck

Clearances 0

Regulation 21 CFR 876.4730

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FHL Class 1

Scoop

Clearances 0

Regulation 21 CFR 876.4730

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FHW Class 3

Device, Impotence, Mechanical/Hydraulic

Clearances 0

Regulation 21 CFR 876.3350

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FHY Class 2

Jelly, Contact, For Transurethral Surgical Instrument

Clearances 0

Regulation 21 CFR 876.4300

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FHZ Class 2

Desiccator, Transurethral

Clearances 0

Regulation 21 CFR 876.4300

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FIA Class 1

Chair, Dialysis, Unpowered, Without Scales

Clearances 0

Regulation 21 CFR 876.5820

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FIK Class 2

System, Dialysate Delivery, Recirculating

Clearances 0

Regulation 21 CFR 876.5820

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FIS Class 2

Flowmeter, Dialysate

Clearances 0

Regulation 21 CFR 876.5820

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FJA Class 2

Manometer, Water

Clearances 0

Regulation 21 CFR 876.5820

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FJJ Class 2

Dialyzer, Twin Coil

Clearances 0

Regulation 21 CFR 876.5820

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FJM Class 2

Guard, Shunt

Clearances 0

Regulation 21 CFR 876.5540

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FJN Class 2

Stabilizer, Shunt

Clearances 0

Regulation 21 CFR 876.5540

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FJO Class 1

Plier, Tube

Clearances 0

Regulation 21 CFR 876.5540

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FJP Class 2

Adaptor, Y

Clearances 0

Regulation 21 CFR 876.5820

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FJR Class 1

Forceps, Disconnect

Clearances 0

Regulation 21 CFR 876.5540

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FJW Class 1

Ring, Joint

Clearances 0

Regulation 21 CFR 876.5540

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FJX Class 1

Ring, Crimp

Clearances 0

Regulation 21 CFR 876.5540

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FJY Class 1

Plier, Crimp

Clearances 0

Regulation 21 CFR 876.5540

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FKE Class 1

Tie, Dialysis

Clearances 0

Regulation 21 CFR 876.5820

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FKF Class 1

Gun, Tie, Dialysis

Clearances 0

Regulation 21 CFR 876.5820

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FKM Class 2

Adaptor, Fistula

Clearances 0

Regulation 21 CFR 876.5820

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FTJ Class 2

Colonoscope, General & Plastic Surgery

Clearances 0

Regulation 21 CFR 876.1500

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FTO Class 3

Prosthesis, Testicle

Clearances 0

Regulation 21 CFR 876.3750

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GBL Class N

Catheter, Ureteral, General & Plastic Surgery

Clearances 0

Regulation 21 CFR 876.5130

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GCG Class 2

Peritoneoscope

Clearances 0

Regulation 21 CFR 876.1500

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GCH Class 2

Mediastinoscope, Diagnostic

Clearances 0

Regulation 21 CFR 876.1500

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GCK Class 2

Gastroscope, General & Plastic Surgery

Clearances 0

Regulation 21 CFR 876.1500

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GCN Class 2

Endoscope, Prism

Clearances 0

Regulation 21 CFR 876.1500

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JCW Class 3

Prosthesis, Penis, Inflatable

Clearances 0

Regulation 21 CFR 876.3350

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KQR Class 2

Detector, Air Or Foam

Clearances 0

Regulation 21 CFR 876.5820

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LCG Class 2

Intestinal Splinting Tubes

Clearances 0

Regulation 21 CFR 876.5980

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MON Class 1

System, Hemodialysis, Remote Accessories

Clearances 0

Regulation 21 CFR 876.5820

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MSZ Class 2

Strip, Test, Reagent, Residuals For Dialysate

Clearances 0

Regulation 21 CFR 876.5665

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NIF Class 2

Catheter, Hemodialysis, Triple Lumen, Implanted

Clearances 0

Regulation 21 CFR 876.5540

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NIH Class 2

Disinfectant, Subsystem, Water Purification

Clearances 0

Regulation 21 CFR 876.5665

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NKZ Class 2

Endoilluminator, Reprocessed

Clearances 0

Regulation 21 CFR 876.1500

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NLS Class 2

Instrument, Biopsy, Reprocessed

Clearances 0

Regulation 21 CFR 876.1075

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NLT Class 2

Snare, Flexible, Reprocessed

Clearances 0

Regulation 21 CFR 876.4300

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NLV Class 2

Electrode, Flexible Suction Coagulator, Reprocessed

Clearances 0

Regulation 21 CFR 876.4300

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NLX Class 2

Needle, Pneumoperitoneum, Spring Loaded, Reprocessed

Clearances 0

Regulation 21 CFR 876.1500

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NMX Class 2

Needle And Needle Set, Gastro-Urology, Reprocessed

Clearances 0

Regulation 21 CFR 876.1075

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NMY Class 2

Needle, Endoscopic, Reprocessed

Clearances 0

Regulation 21 CFR 876.1500

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NNE Class 2

Needle, Fistula, Reprocessed

Clearances 0

Regulation 21 CFR 876.5540

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NNG Class 2

Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

Clearances 0

Regulation 21 CFR 876.5820

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NNW Class 1

Bag, Urine Collection, Leg, For External Use, Non-Sterile

Clearances 0

Regulation 21 CFR 876.5250

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NNX Class 1

Device, Incontinence, Urosheath Type, Non-Sterile

Clearances 0

Regulation 21 CFR 876.5250

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NNY Class 1

Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile

Clearances 0

Regulation 21 CFR 876.5250

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NNZ Class 1

System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile

Clearances 0

Regulation 21 CFR 876.5250

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NOA Class 1

Device, Paste-On For Incontinence, Non-Sterile

Clearances 0

Regulation 21 CFR 876.5250

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NOO Class 1

Clamp, Dialysis Arm

Clearances 0

Regulation 21 CFR 876.5540

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NQT Class 2

Dislodger, Stone, Flexible, Ureteral, Reprocessed

Clearances 0

Regulation 21 CFR 876.4680

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NQU Class 2

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Clearances 0

Regulation 21 CFR 876.4680

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NQV Class 1

Catheter, Suction, Tracheobronchial, Reprocessed

Clearances 0

Regulation 21 CFR 876.4680

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NUB Class 3

Colonic Irrigation System, General Well Being

Clearances 0

Regulation 21 CFR 876.5220

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NWI Class 2

Electrosurgical Electrode Kit

Clearances 0

Regulation 21 CFR 876.4300

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NWP Class 2

Suprapubic Cystostomy Catheter Kit

Clearances 0

Regulation 21 CFR 876.5090

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NWT Class 2

Endoscopic Cholangiogram Kit

Clearances 0

Regulation 21 CFR 876.1500

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ODN Class 2

Ultrafiltration-Controlled Nocturnal Dialysate Delivery System

Clearances 0

Regulation 21 CFR 876.5860

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OEJ Class 2

Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia

Clearances 0

Regulation 21 CFR 876.4300

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OEK Class 2

Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia

Clearances 0

Regulation 21 CFR 876.4300

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OHR Class 2

Catheter Care Tray

Clearances 0

Regulation 21 CFR 876.5130

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OLH Class 1

Orchidometer

Clearances 0

Regulation 21 CFR 876.4730

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OQT Class 2

Prostate Lesion, Documentation, System

Clearances 0

Regulation 21 CFR 876.2050

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PEV Class 2

Dialysis Administration Kit

Clearances 0

Regulation 21 CFR 876.5820

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PGU Class 2

Spatial Imaging For Display Of Endoscope Position

Clearances 0

Regulation 21 CFR 876.1500

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PHT Class 1

Basin For Endoscope Reprocessing

Clearances 0

Regulation 21 CFR 876.1500

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PIA Class 2

Vibrator For Climax Control Of Premature Ejaculation

Clearances 0

Regulation 21 CFR 876.5025

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PIH Class 2

Urethral Insert With Pump For Bladder Drainage

Clearances 0

Regulation 21 CFR 876.5140

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PIN Class 2

Kidney Perfusion Kit

Clearances 0

Regulation 21 CFR 876.5880

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PJH Class 2

Dynamic Rectal Control System

Clearances 0

Regulation 21 CFR 876.5930

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PKI Class 2

Fully Subcutaneous Implanted Hemodialysis Catheter

Clearances 0

Regulation 21 CFR 876.5540

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PNB Class 2

Biliary Stent System For Benign Strictures

Clearances 0

Regulation 21 CFR 876.5011

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POZ Class 2

Biopsy Needle Kit

Clearances 0

Regulation 21 CFR 876.1075

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PPA Class 2

Bladder Irrigation Kit

Clearances 0

Regulation 21 CFR 876.5130

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PPB Class 2

Foley Catheter Kit (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 876.5130

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PPC Class 2

Male External Catheterization Kit (Excludes Hiv Testing)

Clearances 0

Regulation 21 CFR 876.5130

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PPD Class 2

Universal Drainage Tray

Clearances 0

Regulation 21 CFR 876.5130

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PPE Class 2

Nephroscope Set

Clearances 0

Regulation 21 CFR 876.1500

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PPF Class 2

Urinary Irrigation Kit

Clearances 0

Regulation 21 CFR 876.5130

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PPG Class 2

Urinary Drainage Collection Kit

Clearances 0

Regulation 21 CFR 876.5130

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PPH Class 2

Single Needle With Uni-Directional Pump Kit

Clearances 0

Regulation 21 CFR 876.5820

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PPI Class 2

Hemodialysis Tray (Not A Start/Stop Kit)

Clearances 0

Regulation 21 CFR 876.5820

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PPJ Class 2

Peritoneal Dialysis Administration Kit

Clearances 0

Regulation 21 CFR 876.5630

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PPK Class 2

Peritoneal Dialysis Tubing Kit

Clearances 0

Regulation 21 CFR 876.5630

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PPL Class 2

Single Needle (Co-Axial Flow) Dialysis Kit

Clearances 0

Regulation 21 CFR 876.5820

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PPO Class 2

Multi-Lumen Hemodialysis Catheterization Kit

Clearances 0

Regulation 21 CFR 876.5540

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PQE Class 1

Ostomy Care Kit

Clearances 0

Regulation 21 CFR 876.5900

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PRM Class 2

Enteral Administration Kit (Adult & Pediatric)

Clearances 0

Regulation 21 CFR 876.5980

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PRO Class 2

Anti-Regurgitation Blood Tubing Kit

Clearances 0

Regulation 21 CFR 876.5820

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PRP Class 2

Balloon Gastrostomy Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRQ Class 2

Esophageal Dilator Kit

Clearances 0

Regulation 21 CFR 876.5365

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PRR Class 2

Feeding Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRS Class 2

Gastric Colonic Catheter Irrigation Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRT Class 2

Gastric Irrigation And Aspiration Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRU Class 2

Gastric Lavage Kit (Adult Or Pediatric Use)

Clearances 0

Regulation 21 CFR 876.4370

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PRV Class 2

Gastro-Urology Biopsy Kit

Clearances 0

Regulation 21 CFR 876.1075

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PRW Class 2

Gastrointestinal Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRX Class 2

Gastrostomy Guide Wire Placement Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRY Class 2

Gastrostomy Jejunostomy Feeding Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PRZ Class 2

Gastrostomy Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSA Class 2

Laparoscopic Jejunostomy Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSB Class 2

Nasogastric Feed Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSC Class 2

Nasogastric-Gastrojejunal Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSD Class 2

Laparoscopic Gastrostomy Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSE Class 2

Needle Catheter Jejunostomy Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSF Class 2

Non-Balloon Replacement Gastrostomy System

Clearances 0

Regulation 21 CFR 876.5980

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PSG Class 2

Percutaneous Endoscopic Gastrostomy Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSH Class 2

Percutaneous Replacement Gastrostomy Tube Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSI Class 2

Perineal Irrigation Kit

Clearances 0

Regulation 21 CFR 876.5980

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PSJ Class 1

Rectal Dilator Kit

Clearances 0

Regulation 21 CFR 876.5450

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PSK Class 2

Replacement Gastrostomy Feeding Catheter Tray

Clearances 0

Regulation 21 CFR 876.5980

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PTK Class 3

Pediatric Esophageal Atresia Anastomosis Device

Clearances 0

Regulation 21 CFR 876.5980

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PTQ Class 2

Endoscopic Magnetic Retriever, Exempt

Clearances 0

Regulation 21 CFR 876.1500

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PTR Class 2

Scissors For Cytoscope, Exempt

Clearances 0

Regulation 21 CFR 876.1500

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PTS Class 2

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Clearances 0

Regulation 21 CFR 876.1500

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PTT Class 2

Biliary Catheter For Irrigation And Contrast Injection, Exempt

Clearances 0

Regulation 21 CFR 876.5010

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PTU Class 2

Catheter, Peritoneal, Long-Term Indwelling, Exempt

Clearances 0

Regulation 21 CFR 876.5630

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PTV Class 2

Catheter, Peritoneal Dialysis, Single Use, Exempt

Clearances 0

Regulation 21 CFR 876.5630

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PTW Class 2

System, Peritoneal, Automatic Delivery, Exempt

Clearances 0

Regulation 21 CFR 876.5630

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PVY Class 1

Vasovasostomy Set

Clearances 0

Regulation 21 CFR 876.4730

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QEF Class 1

Pressure Ulcer Management Tool

Clearances 0

Regulation 21 CFR 876.2100

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QFZ Class 1

Gastroenterology-Urology Accessories To A Biopsy Instrument

Clearances 0

Regulation 21 CFR 876.1080

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QGA Class 1

Penile Implant Surgical Accessories

Clearances 0

Regulation 21 CFR 876.3500

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QGB Class 1

Ureteral Stent Accessories

Clearances 0

Regulation 21 CFR 876.4630

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QGC Class 1

Suprapubic Catheter Accessories

Clearances 0

Regulation 21 CFR 876.5100

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QGD Class 1

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

Clearances 0

Regulation 21 CFR 876.5290

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QGE Class 1

Biliary Stent, Drain, And Dilator Accessories

Clearances 0

Regulation 21 CFR 876.5012

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QHC Class 2

Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

Clearances 0

Regulation 21 CFR 876.1075

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QIJ Class 2

Endoscopic Transhepatic Venous Access Needle

Clearances 0

Regulation 21 CFR 876.1050

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QIR Class 2

Pediatric Hemodialysis System

Clearances 0

Regulation 21 CFR 876.5861

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QNE Class 2

Endoscopic Pancreatic Debridement Device

Clearances 0

Regulation 21 CFR 876.4330

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QON Class 3

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

Clearances 0

Regulation 21 CFR 876.5270

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QTH Class 2

Endoscopic Light-Projecting Measuring Device

Clearances 0

Regulation 21 CFR 876.1530

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QUD Class 2

Blood Detection Capsule

Clearances 0

Regulation 21 CFR 876.1390

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QUN Class 2

Tether Accessory For Use In The Gastrointestinal Tract

Clearances 0

Regulation 21 CFR 876.1305

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QWW Class 2

Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Clearances 0

Regulation 21 CFR 876.5021

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QXH Class 2

Gallbladder Drainage Stent And Delivery System

Clearances 0

Regulation 21 CFR 876.5016

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SBX Class 2

Software For Endoscopy Procedure Metrics

Clearances 0

Regulation 21 CFR 876.1500

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SCB Class 2

Deflation Needle For Removal Of Intragastric Balloon

Clearances 0

Regulation 21 CFR 876.1550

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SCT Class 2

Foley Catheters And Accessories With Additional Safety Features

Clearances 0

Regulation 21 CFR 876.5130

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SFW Class 1

Cranial Electrotherapy Stimulator For Weight Management

Clearances 0

Regulation 21 CFR 876.5984

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SGY Class 2

Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

Clearances 0

Regulation 21 CFR 876.5881

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SHV Class 2

Reusable Intermittent Urinary Catheter System

Clearances 0

Regulation 21 CFR 876.5120

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SJB Class 2

Powered Fecal Management System

Clearances 0

Regulation 21 CFR 876.5230

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