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
8353–8376 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 31, 1984
GASTROINTESTINAL DILATOR
K841310 · KNQ
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 123d
Cleared Jul 31, 1984
PACKETS FOR THE PREP OF DIALYSATES &
K842154 · FKQ
Organon Teknika Corp.
Gastroenterology & Urology · 62d
Cleared Jul 26, 1984
SALIVARY BYPASS TUBE
K841350
E. Benson Hood Laboratories, Inc.
Gastroenterology & Urology · 115d
Cleared Jul 26, 1984
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
K841720 · LJE
E-Z-Em, Inc.
Gastroenterology & Urology · 92d
Cleared Jul 26, 1984
LFT - 212
K841879 · LIL
Medical Monitoring Systems, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 26, 1984
ENTERAL FEEDING BOTTLE
K841945 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 76d
Cleared Jul 26, 1984
HEMODIALYSIS BATH CONCENTRATE SOLUTION
K842058 · FKQ
Pharmaceutical Development Systems
Gastroenterology & Urology · 65d
Cleared Jul 26, 1984
DUO FLOW CATHETER-MC 54
K842416 · KNZ
Medical Components, Inc.
Gastroenterology & Urology · 36d
Cleared Jul 23, 1984
ESOPHAGEAL TUBE
K841349 · KNT
E. Benson Hood Laboratories, Inc.
Gastroenterology & Urology · 112d
Cleared Jul 20, 1984
CHESEBROUGH-POND'S REUSABLE URINARY LEG
K842553 · KNX
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 18d
Cleared Jul 19, 1984
PROXIMA 1 PH MONITOR
K841384 · FFT
American Endoscopy, Inc.
Gastroenterology & Urology · 121d
Cleared Jul 19, 1984
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 19, 1984
CORPAK FOLEY CATH TRAY W/16FR. TEFLON
K841819 · KOD
Corpak Co.
Gastroenterology & Urology · 78d
Cleared Jul 19, 1984
SEGURA BASKET
K841942 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 69d
Cleared Jul 19, 1984
ULTRA SHIELD BRIEFS
K841953 · EYQ
Ipco Corp.
Gastroenterology & Urology · 66d
Cleared Jul 17, 1984
COLON IRRIGATION UNIT
K840613 · KPL
Colenz Co.
Gastroenterology & Urology · 155d
Cleared Jul 16, 1984
ADAPTOR HR-3000 REUSE
K841153 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 13, 1984
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
K842436 · KOC
Erika, Inc.
Gastroenterology & Urology · 23d
Cleared Jul 12, 1984
HAEMATURIA CATHETERS
K841511 · KOD
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 92d
Cleared Jul 09, 1984
OSTOMY FREEDOM KIT
K841173 · EXB
Ellenberg Assoc.
Gastroenterology & Urology · 112d
Cleared Jul 09, 1984
CYSTO-AID
K841197 · KNX
E-Z-Em, Inc.
Gastroenterology & Urology · 110d
Cleared Jul 09, 1984
FOREIGN BODY PROTECTOR
K841258 · FED
Jayco Pharmaceuticals
Gastroenterology & Urology · 105d
Cleared Jul 09, 1984
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · KNT
Burron Medical Products, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 09, 1984
AMER. PHARMASEAL SILICONIZED LATEX
K841544 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 84d