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
3145–3168 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 17, 2006
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
K062399 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 93d
Cleared Nov 09, 2006
KARL STORZ VIDEO GASTROSCOPES
K060907 · FDS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 220d
Cleared Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 111d
Cleared Nov 07, 2006
I-STOP TRANS OBTURATOR MALE SLING
K063079 · OTM
Cl Medical
Gastroenterology & Urology · 28d
Cleared Nov 03, 2006
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER...
K062671 · MSD
Kendall
Gastroenterology & Urology · 56d
Cleared Nov 02, 2006
LITHOGOLD
K062081 · LNS
Tissue Regeneration Technologies, Inc.
Gastroenterology & Urology · 104d
Cleared Nov 02, 2006
MALE REMEEX SYSTEM
K062341 · OTM
Specialities Remeex International, S.L.
Gastroenterology & Urology · 84d
Cleared Oct 27, 2006
SUPERCATH V
K052267 · FIE
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 434d
Cleared Oct 20, 2006
INTEGRA SL
K062147 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 85d
Cleared Oct 20, 2006
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2006
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Oct 18, 2006
PRISMA SYSTEM R03.10A
K062090 · KDI
Gambro Renal Products
Gastroenterology & Urology · 86d
Cleared Oct 18, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K062786 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 30d
Cleared Oct 16, 2006
CAREVENT
K062240 · KNY
Chief Medical, LLC
Gastroenterology & Urology · 75d
Cleared Oct 13, 2006
COLOPLAST OSTOMY ROD, MODEL 12814
K052229 · EZP
Coloplast Corp.
Gastroenterology & Urology · 423d
Cleared Oct 13, 2006
MODIFICATION TO ENDO-EASE
K062805 · FED
Spirus Medical, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 11, 2006
VANGUARD REPROCESSED SUTURE PASSER
K053585 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 292d
Cleared Oct 10, 2006
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563...
K060538 · MNW
Beaverite International Limited
Gastroenterology & Urology · 224d
Cleared Oct 05, 2006
URASSIST
K062061 · NZU
Preferred Medical Devices, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 02, 2006
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · OCW
Arthrocare Corp.
Gastroenterology & Urology · 60d
Cleared Sep 29, 2006
MAXIFLEX-SEMI FLEX SCOPE
K062725 · FGB
Technology Delivery Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Sep 28, 2006
STRYKER URETERAL ILLUMINATION SYSTEM IV
K061548 · FCS
Stryker Corp.
Gastroenterology & Urology · 115d
Cleared Sep 25, 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 94d
Cleared Sep 22, 2006
EVIS EXERA II 180 SYSTEM
K062049 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 64d