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

3073–3096 of 9,870

Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology

Cleared May 08, 2007

RESONANCE METALLIC URETERAL STENT

Cook Ireland, Ltd.

Gastroenterology & Urology · 141d

Cleared May 07, 2007

MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM

Given Imaging , Ltd.

Gastroenterology & Urology · 76d

Cleared May 04, 2007

UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES

Laborie Medical Technologies

Gastroenterology & Urology · 88d

Cleared Apr 30, 2007

DELTACUT (APPARATUS AND CANNULA)

PAJUNK GmbH Medizintechnologie

Gastroenterology & Urology · 187d

Cleared Apr 27, 2007

MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

Chf Solutions, Inc.

Gastroenterology & Urology · 64d

Cleared Apr 24, 2007

FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N

Fresenius Medical Care North America

Gastroenterology & Urology · 90d

Cleared Apr 24, 2007

THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

Avantis Medical Systems, Inc.

Gastroenterology & Urology · 78d

Cleared Apr 24, 2007

BARD MALECOT AND PEZZER DRAINS

C.R. Bard, Inc.

Gastroenterology & Urology · 25d

Cleared Apr 18, 2007

COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208

Cardinal Health, Inc.

Gastroenterology & Urology · 98d

Cleared Apr 13, 2007

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY...

Gastroenterology & Urology · 242d

Cleared Apr 06, 2007

OPUS SMARTSTITCH SUTURE DEVICE

Arthrocare Corp.

Gastroenterology & Urology · 25d

Cleared Apr 05, 2007

MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM

Mini Lap Technologies, Inc.

Gastroenterology & Urology · 58d

Cleared Apr 05, 2007

MINI LAP INSTRUMENTS

Mini Lap Technologies, Inc.

Gastroenterology & Urology · 24d

Cleared Apr 02, 2007

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

Viasys Medsystems

Gastroenterology & Urology · 179d

Cleared Mar 30, 2007

IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS

Impedimed Pty , Ltd.

Gastroenterology & Urology · 770d

Cleared Mar 29, 2007

FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES

Fresenius Medical Care North America

Gastroenterology & Urology · 70d

Cleared Mar 26, 2007

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

Degania Silicone , Ltd.

Gastroenterology & Urology · 132d

Cleared Mar 23, 2007

EDWARDS AQUALINE STERILE TUBING SET

Edwards Lifesciences Services GmbH

Gastroenterology & Urology · 142d

Cleared Mar 22, 2007

S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES

Richard Wolf Medical Instruments Corp.

Gastroenterology & Urology · 191d

Cleared Mar 21, 2007

ALIGN URETHRAL SUPPORT SYSTEM

C.R. Bard, Inc.

Gastroenterology & Urology · 72d

Cleared Mar 19, 2007

BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138

United States Endoscopy Group, Inc.

Gastroenterology & Urology · 27d

Cleared Mar 16, 2007

FUJINON MODEL EG-530N TRANS NASAL INSERTION

Gastroenterology & Urology · 134d

Cleared Mar 15, 2007

UNITIP HIGH RESOLUTION CATHETER

Gastroenterology & Urology · 225d

Cleared Mar 15, 2007

GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

Marian Medical, Inc.

Gastroenterology & Urology · 71d