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

3481–3504 of 9,870

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

Cleared Aug 31, 2004

SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)

Gastroenterology & Urology · 132d

Cleared Aug 27, 2004

USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM

Gastroenterology & Urology · 472d

Cleared Aug 27, 2004

ACCUSOL DIALYSIS SOLUTION

Baxter Healthcare Corp

Gastroenterology & Urology · 91d

Cleared Aug 27, 2004

B. BRAUN BICARBONATE DIALYSATE

B.Braun Medical, Inc.

Gastroenterology & Urology · 67d

Cleared Aug 27, 2004

NXSTAGE PUREFLOW-B SOLUTION

Nxstage Medical, Inc.

Gastroenterology & Urology · 28d

Cleared Aug 26, 2004

STORZ MODULITH, MODEL SLX-F2

KARL STORZ Endoscopy-America, Inc.

Gastroenterology & Urology · 184d

Cleared Aug 25, 2004

NANMA VACUUM PUMP PROXZEK MODEL 2M9498S

Nanma Mfg Co., Ltd.

Gastroenterology & Urology · 72d

Cleared Aug 23, 2004

MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT

Gastroenterology & Urology · 7d

Cleared Aug 19, 2004

ULTRASOUND LOCALIZATION SYSTEM ULS 0142

Hmt High Medical Technologies AG

Gastroenterology & Urology · 149d

Cleared Aug 19, 2004

MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207

Richard Wolf Medical Instruments Corp.

Gastroenterology & Urology · 65d

Cleared Aug 16, 2004

JMS BLOOD TUBING SETS

Jms North America Corp.

Gastroenterology & Urology · 327d

Cleared Aug 11, 2004

SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS

American Medical Systems, Inc.

Gastroenterology & Urology · 22d

Cleared Aug 09, 2004

STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM

Stryker Endoscopy

Gastroenterology & Urology · 314d

Cleared Aug 09, 2004

PERFORMANCE WATER TREATMENT SYSTEM

Performance Water Systems, LLC

Gastroenterology & Urology · 263d

Cleared Aug 03, 2004

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

Cordis Corporation

Gastroenterology & Urology · 32d

Cleared Jul 30, 2004

55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL...

Spire Biomedical, Inc.

Gastroenterology & Urology · 50d

Cleared Jul 29, 2004

15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706

Gastroenterology & Urology · 104d

Cleared Jul 23, 2004

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER,...

Asahi Medical Co., Ltd.

Gastroenterology & Urology · 28d

Cleared Jul 22, 2004

TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE

Tanita Corp. of America

Gastroenterology & Urology · 98d

Cleared Jul 22, 2004

COOK SIDEARM CORE TISSUE BIOPSY DEVICE

Urological, Inc.

Gastroenterology & Urology · 43d

Cleared Jul 21, 2004

VIABIL BILIARY ENDOPROSTHESIS

W.L. Gore & Associates, Inc.

Gastroenterology & Urology · 54d

Cleared Jul 20, 2004

DOVER ROB-NEL CATHETER

Tyco Healthcare

Gastroenterology & Urology · 105d

Cleared Jul 09, 2004

CORE NEEDLE BIOPSY

Remington Medical, Inc.

Gastroenterology & Urology · 155d

Cleared Jul 08, 2004

INJECTOR NEEDLE/SNARE

United States Endoscopy Group, Inc.

Gastroenterology & Urology · 86d