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
3625–3648 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 21, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314 · FGE
Ev3, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 20, 2003
SYSTEM 100 ULTRAFILTRATION CATHETER
K023874 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 364d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q,...
K031676 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 174d
Cleared Nov 20, 2003
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
K033593 · NLU
Clearmedical, Inc.
Gastroenterology & Urology · 7d
Cleared Nov 17, 2003
STONE EXTRACTOR BALLOON CATHETER
K011261 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 936d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · FGE
Ev3, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 14, 2003
AUTO-BAND LIGATOR
K031236 · MND
Scandimed. A.S.
Gastroenterology & Urology · 210d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521 · EYB
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 14, 2003
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · FGE
Guidant Corp.
Gastroenterology & Urology · 18d
Cleared Nov 10, 2003
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K033427 · KNW
Neothermia Corp.
Gastroenterology & Urology · 13d
Cleared Nov 06, 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 30, 2003
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K023509 · KDI
Davita Clinical Research (Trri)
Gastroenterology & Urology · 377d
Cleared Oct 30, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS
K033212 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 27d
Cleared Oct 29, 2003
AMSURE FOLEY CATHETER
K030120 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 289d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 86d
Cleared Oct 29, 2003
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
K033126 · LIL
Behavioral Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 28, 2003
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 27, 2003
PERFADEX SOLUTION FOR LUNG PRESERVATION
K022730 · MSB
Vitrolife AB
Gastroenterology & Urology · 437d
Cleared Oct 23, 2003
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
K032530 · FGE
Guidant Corporation
Gastroenterology & Urology · 69d
Cleared Oct 23, 2003
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
K032820 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 43d
Cleared Oct 23, 2003
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 31d
Cleared Oct 22, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580 · FGE
Ev3, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 22, 2003
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT...
K032929 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 30d