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
2209–2232 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 02, 2013
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
K121370 · FHO
Vectec
Gastroenterology & Urology · 452d
Cleared Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM...
K122091 · MPB
Cook, Inc.
Gastroenterology & Urology · 378d
Cleared Jul 26, 2013
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
K130623 · KNS
Covidien, LLC
Gastroenterology & Urology · 140d
Cleared Jul 26, 2013
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
K131814 · MSD
Ameco Medical Industries
Gastroenterology & Urology · 36d
Cleared Jul 17, 2013
ENDOFLIP CATHETER
K130906 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 107d
Cleared Jul 11, 2013
NXSTAGE DOSING CALCULATOR
K130460 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 11, 2013
NEXUS HEMORRHOID LIGATOR
K131282 · FHN
Inx Medical
Gastroenterology & Urology · 66d
Cleared Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC...
K131072 · OCY
Coloplast A/S
Gastroenterology & Urology · 83d
Cleared Jul 03, 2013
2008K@HOME HEMODIALYSIS MACHINE
K124035 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 187d
Cleared Jun 26, 2013
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653 · KNT
Kimberly Clark Corporation
Gastroenterology & Urology · 299d
Cleared Jun 26, 2013
HEMOCONCENTRATOR
K123288 · KDI
Maquet Cardiopulmonary, AG
Gastroenterology & Urology · 247d
Cleared Jun 23, 2013
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
K131524 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 19, 2013
CLL- V1 LIGHT SOURCE
K130819 · NTN
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 86d
Cleared Jun 14, 2013
BEL-GEN COLD STORAGE SOLUTION
K121618 · KDL
Waters Medical Systems, LLC
Gastroenterology & Urology · 378d
Cleared Jun 14, 2013
AMIA AUTOMATED PD SYSTEM
K124018 · FKX
Deka Research & Development Corp.
Gastroenterology & Urology · 169d
Cleared Jun 11, 2013
T3
K123292 · NIE
Medcomp
Gastroenterology & Urology · 232d
Cleared Jun 06, 2013
NATRATONE
K121902 · HIR
Orelle Corporation, Ltd.
Gastroenterology & Urology · 342d
Cleared May 31, 2013
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
K130338 · OBH
ImpediMed Limited
Gastroenterology & Urology · 109d
Cleared May 30, 2013
TRANSTEK BODY FAT ANALYZER
K130311 · MNW
Guangdong Transtek Medical...
Gastroenterology & Urology · 111d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · EZN
Boston Scientific Corporation
Gastroenterology & Urology · 58d
Cleared May 20, 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K123428 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 194d
Cleared May 17, 2013
SCOPEVALET DISPOSABLE BIOPSY VALVE
K122417 · OCX
The Ruhof Corp.
Gastroenterology & Urology · 282d
Cleared May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · OCX
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared May 14, 2013
HYDROSIL
K122785 · EZD
Rochester Medical Corp.
Gastroenterology & Urology · 245d