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
2881–2904 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 27, 2008
UC-CARE POSITIONING SYSTEM
K082919 · EZL
Uc-Care Medical Systems, Ltd.
Gastroenterology & Urology · 27d
Cleared Oct 24, 2008
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
K081587 · MNW
Krell Precision (Yang Zhou) Co., Ltd.
Gastroenterology & Urology · 141d
Cleared Oct 23, 2008
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K080944 · LJE
C.R. Bard, Inc.
Gastroenterology & Urology · 203d
Cleared Oct 23, 2008
AMSELF CLOSED CATHETERIZATION SYSTEM
K082831 · FCM
Amsino International, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 21, 2008
XCHF-T160 VIDEOSCOPE
K082576 · FBN
Olympus Medical Systems Corporation
Gastroenterology & Urology · 46d
Cleared Oct 20, 2008
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K082006 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 97d
Cleared Oct 17, 2008
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
K082640 · OTM
Coloplast Manufacturing Us, LLC
Gastroenterology & Urology · 37d
Cleared Oct 15, 2008
NXSTAGE PUREFLOW SL
K080919 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Oct 15, 2008
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 10, 2008
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI...
K082046 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 09, 2008
PERFADEX WITH THAM
K081997 · MSB
Vitrolife Sweden AB
Gastroenterology & Urology · 87d
Cleared Oct 08, 2008
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
K082815 · EZL
Well Lead Medical Instruments
Gastroenterology & Urology · 13d
Cleared Oct 03, 2008
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
K080825 · OBH
Impedimed Pty , Ltd.
Gastroenterology & Urology · 193d
Cleared Oct 03, 2008
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX,...
K082515 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 31d
Cleared Oct 01, 2008
NEOMED POLYURETHANE FEEDING TUBE
K082238 · FPD
Neomed, Inc.
Gastroenterology & Urology · 55d
Cleared Sep 25, 2008
CHOOSTENT
K072094 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 423d
Cleared Sep 25, 2008
INJEKT FILIFORM INJECTION NEEDLE
K082319 · FBK
Cook Urological, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 19, 2008
MODIFIED ENDO STICH
K082659 · OCW
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 7d
Cleared Sep 17, 2008
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 100d
Cleared Sep 12, 2008
KEGEL8 PELVIC EXERCISER, MODEL OPH 400
K081480 · KPI
Ne Services , Ltd.
Gastroenterology & Urology · 108d
Cleared Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280,...
K080332 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 211d
Cleared Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
K081275 · PAH
Boston Scientific Corp
Gastroenterology & Urology · 114d
Cleared Aug 26, 2008
TAXI ENDOSCOPIC GUIDEWIRE
K081708 · OCY
Lake Region Mfg., Inc.
Gastroenterology & Urology · 70d
Cleared Aug 22, 2008
OHMNISCAN NG
K073334 · MNW
Christine Valmy, Inc.
Gastroenterology & Urology · 268d