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
6937–6960 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
K896599 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 121d
Cleared Mar 22, 1990
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
K896600 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 121d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900008 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 79d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900012 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 79d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
K900140 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
K900141 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
K900142 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
K900226 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 64d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
K900242 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 64d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6
K900243 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 64d
Cleared Mar 22, 1990
PERITONEAL DIALYSIS CYCLER SET
K900323 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 58d
Cleared Mar 20, 1990
ERECTION INDUCER DEVICE (EID)
K896060 · LKY
Performance Medical, Inc.
Gastroenterology & Urology · 153d
Cleared Mar 20, 1990
LABELING CHANGE - VIASPAN(TM) (BELZER UW)
K900492 · KDL
The DU Pont Co.
Gastroenterology & Urology · 46d
Cleared Mar 19, 1990
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · KDH
Baxter Healthcare Corp
Gastroenterology & Urology · 74d
Cleared Mar 15, 1990
NON-ELECTRIC BIOPSY FORCEPS
K900015 · FCL
Esco Precision, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 15, 1990
BJ STAR ALL SILICONE FOLEY BALLOON CATHETER
K900022 · KOD
B.J. Star, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 15, 1990
NON-ELECTRIC BIOPSY FORCEPS
K900065 · FCL
Esco Precision, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 13, 1990
SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS
K894300 · FIP
U.S. Filter/Continental Water Systems
Gastroenterology & Urology · 264d
Cleared Mar 13, 1990
L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
K895824 · FPD
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 165d
Cleared Mar 13, 1990
INFANT FEEDING TUBE
K896559 · FPD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 116d
Cleared Mar 07, 1990
ERECTION DEVICE
K896061 · LKY
Clyde Engineering Service
Gastroenterology & Urology · 140d
Cleared Mar 07, 1990
BALLOON DILATION CATHETER
K896448 · EZN
Cook Ob/Gyn
Gastroenterology & Urology · 118d
Cleared Mar 07, 1990
WILSON-COOK COLON DECOMPRESSION SET
K900035 · FEG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 06, 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 83d