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

3409–3432 of 9,870

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

Cleared Feb 01, 2005

UPDATED SLIP UROLOGY INTRODUCER SHEATH

Percutaneous Systems, Incorporated

Gastroenterology & Urology · 137d

Cleared Jan 28, 2005

INFANT FEEDING TUBE

Marian Medical, Inc.

Gastroenterology & Urology · 176d

Cleared Jan 28, 2005

EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1

Aizu Olympus Co., Ltd.

Gastroenterology & Urology · 42d

Cleared Jan 25, 2005

VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS

Vanguard Medical Concepts, Inc.

Gastroenterology & Urology · 124d

Cleared Jan 19, 2005

OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400

Omron Healthcare, Inc.

Gastroenterology & Urology · 75d

Cleared Jan 18, 2005

DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER

Tyco Healthcare

Gastroenterology & Urology · 110d

Cleared Jan 11, 2005

INBODY, MODEL 3.0

Biospace Corporation Limited

Gastroenterology & Urology · 116d

Cleared Jan 06, 2005

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

Gambro Renal Products

Gastroenterology & Urology · 73d

Cleared Dec 30, 2004

BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET

Gastroenterology & Urology · 454d

Cleared Dec 29, 2004

MODIFICATION TO: ZILVER 635 BILIARY STENT

Gastroenterology & Urology · 14d

Cleared Dec 23, 2004

TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)

Tanita Corp. of America

Gastroenterology & Urology · 272d

Cleared Dec 23, 2004

LIFESTENT NT35 BILIARY STENT SYSTEM

Edwards Lifesciences, LLC

Gastroenterology & Urology · 55d

Cleared Dec 23, 2004

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

Astra Tech, Inc.

Gastroenterology & Urology · 30d

Cleared Dec 22, 2004

PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP

Gastroenterology & Urology · 26d

Cleared Dec 20, 2004

FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR

Fresenius Medical Care North America

Gastroenterology & Urology · 27d

Cleared Dec 17, 2004

Viasys Medsystems

Gastroenterology & Urology · 147d

Cleared Dec 16, 2004

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02

Teleflex Medical

Gastroenterology & Urology · 22d

Cleared Dec 14, 2004

INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304

American Medical Systems, Inc.

Gastroenterology & Urology · 82d

Cleared Dec 10, 2004

KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE

Kimberly-Clark Corp.

Gastroenterology & Urology · 30d

Cleared Dec 09, 2004

PRIMUS STENT AND DELIVERY SYSTEM

Gastroenterology & Urology · 16d

Cleared Dec 07, 2004

STERICHEK BLOOD LEAK REAGENT STRIPS

Gastroenterology & Urology · 103d

Cleared Dec 07, 2004

BARD INLAYOPTIMA URETERAL STENT WITH SUTURE

C.R. Bard, Inc.

Gastroenterology & Urology · 19d

Cleared Dec 03, 2004

GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

Gastroenterology & Urology · 86d

Cleared Dec 03, 2004

55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS

Spire Biomedical, Inc.

Gastroenterology & Urology · 49d