FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
7417–7440 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 18, 1988
PC POLYGRAF
K872712 · KLA
Synectics-Dantec
Gastroenterology & Urology · 252d
Cleared Mar 16, 1988
REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K871242 · FIP
Medro Systems, Inc.
Gastroenterology & Urology · 355d
Cleared Mar 16, 1988
DRIPRIDE PROVIDE ULTRA
K872059 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 293d
Cleared Mar 16, 1988
JMS APHERESIS NEEDLE
K880726 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 22d
Cleared Mar 15, 1988
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 11, 1988
BLAKEMORE RETAINER
K880253 · FEF
Orthopedic Systems, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 09, 1988
LAKE CATHETER CARE KITS (MODIFICATION)
K875383 · KOD
Lake Medical Products, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 03, 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · FAD
Mentor Corp.
Gastroenterology & Urology · 87d
Cleared Mar 03, 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 43d
Cleared Mar 02, 1988
ULTRA-FRESH DEODORANT
K871313 · GDS
Mentor Corp.
Gastroenterology & Urology · 336d
Cleared Mar 02, 1988
BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
K875119 · FCI
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 78d
Cleared Mar 02, 1988
MIC (SPECIFIC LINE) INSERTION KIT
K875126 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 78d
Cleared Mar 02, 1988
LUER LOCK CONNECTORS / RIDIG P.V.C.
K875188 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 76d
Cleared Mar 02, 1988
CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
K880034 · KNX
Lin-Mark, Inc.
Gastroenterology & Urology · 57d
Cleared Mar 02, 1988
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · FDX
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP
K880096 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC AUTO BIOPSY NEEDLE
K880098 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC BLADDER EVACUATOR
K880099 · KQT
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 22, 1988
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
K880583 · MPB
Quinton, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 19, 1988
LASERTRIPTER MINISCOPE
K874858 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 86d
Cleared Feb 19, 1988
FRESENIUS HEMOFLOW F3, F4, F5, F7
K874872 · FJI
Seratronics, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 19, 1988
AMICON EQUALINE FLUID BALANCE SYSTEM
K875121 · KPF
Amicon, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 19, 1988
UFR DIGITAL RETROFIT
K875312 · FJB
Yankee Intl. Medical Research & Mfg.,...
Gastroenterology & Urology · 52d
Cleared Feb 19, 1988
GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
K880084 · FJI
Gambro, Inc.
Gastroenterology & Urology · 38d