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

3721–3744 of 9,870

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

Cleared Jun 17, 2003

BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000

Baxter Healthcare Corp

Gastroenterology & Urology · 158d

Cleared Jun 17, 2003

URINARY CATHETERS

Gastroenterology & Urology · 43d

Cleared Jun 16, 2003

HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER

C.R. Bard, Inc.

Gastroenterology & Urology · 164d

Cleared Jun 16, 2003

MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

Gastroenterology & Urology · 61d

Cleared Jun 11, 2003

DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER

The Kendall Company Div. of Tyco...

Gastroenterology & Urology · 189d

Cleared Jun 09, 2003

HOBBS MISTIFIER SPRAY CATHETER

Hobbs Medical, Inc.

Gastroenterology & Urology · 90d

Cleared Jun 05, 2003

MODIFICATION TO CAVERMAP SURGICAL AID

Blue Torch Medical Technologies

Gastroenterology & Urology · 21d

Cleared Jun 03, 2003

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH

Acmi Corporation

Gastroenterology & Urology · 90d

Cleared Jun 03, 2003

NANMA VACUUM PUMP

Nanma Mfg Co., Ltd.

Gastroenterology & Urology · 71d

Cleared May 30, 2003

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES...

Primary Care Solutions, Inc.

Gastroenterology & Urology · 77d

Cleared May 30, 2003

MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)

Medtronic Ave, Inc.

Gastroenterology & Urology · 74d

Cleared May 30, 2003

FRESENIUS ULTRAFLUX HEMODIALYZER

Fresenius Medical Care North America

Gastroenterology & Urology · 29d

Cleared May 28, 2003

WATER PURIFICATION SYSTEM

Purity Water Company of San Antonio,...

Gastroenterology & Urology · 306d

Cleared May 23, 2003

PATHWAY STM-10 PELVIC FLOOR STIMULATOR

The Prometheus Group

Gastroenterology & Urology · 137d

Cleared May 23, 2003

GAMBRO POLYFLUX, MODEL 140H, 170H, 210H

Gambro Renal Care Products

Gastroenterology & Urology · 87d

Cleared May 23, 2003

DEFLECTING URETERAL ACCESS SHEATH

Applied Medical Resources Corp.

Gastroenterology & Urology · 84d

Cleared May 23, 2003

AMSURE FOLEY INSERTION TRAY

Amsino International, Inc.

Gastroenterology & Urology · 81d

Cleared May 23, 2003

AMSURE URETHRAL CATHETERIZATION TRAY

Amsino International, Inc.

Gastroenterology & Urology · 78d

Cleared May 23, 2003

NAVIGATOR URETERAL ACCESS SHEATH SET

Boston Scientific Corp

Gastroenterology & Urology · 57d

Cleared May 23, 2003

ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

Ndo Surgical, Inc.

Gastroenterology & Urology · 32d

Cleared May 23, 2003

RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE

Gastroenterology & Urology · 24d

Cleared May 22, 2003

AVITA BF1 (VITALIO) BODY FAT ANALYZER

Avita Corporation

Gastroenterology & Urology · 442d

Cleared May 22, 2003

MODIFICATION TO FOSSA URETERAL STONE SWEEPER

Fossa Medical, Inc.

Gastroenterology & Urology · 29d

Cleared May 21, 2003

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE

Acmi Corporation

Gastroenterology & Urology · 51d