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
8569–8592 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 29, 1983
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 48d
Cleared Nov 29, 1983
RENALLOY HEMASITE VASCULAR ACCESS SHUNT
K833622 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 46d
Cleared Nov 29, 1983
COAXIAL BALLOON URETHRAL DILATOR
K833690 · FAA
American Edwards Laboratories
Gastroenterology & Urology · 42d
Cleared Nov 28, 1983
COAXIAL ELECTRODE #300A
K832566 · FFK
K-Med, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 28, 1983
PRI A PUS
K832756 · LKY
Trans Texas Medical Devices Corp.
Gastroenterology & Urology · 104d
Cleared Nov 28, 1983
MODIFICATION IN MEMBRANE HOUSING CONFI
K832925 · KOC
Ries Biologicals
Gastroenterology & Urology · 101d
Cleared Nov 28, 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 81d
Cleared Nov 28, 1983
ENDOSCOPIC RETROGRADE
K833417 · ODD
Microvasive
Gastroenterology & Urology · 56d
Cleared Nov 28, 1983
NEEDLE CATHETER JEJUNOSTOMY KIT
K833513 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 28, 1983
FEEDING TUBE
K833591 · KNT
Medovations, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 28, 1983
ENTRI FLEX FEEDING TUBE
K833621 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 45d
Cleared Nov 28, 1983
ACTIVE LIFE
K833625 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 45d
Cleared Nov 28, 1983
LUMEN-4 URODYNAMIC CATHETER
K833628 · FAP
Surgitek
Gastroenterology & Urology · 45d
Cleared Nov 28, 1983
D-LYTE
K833653 · KOC
Dialysis Products, Inc.
Gastroenterology & Urology · 39d
Cleared Nov 15, 1983
ASAHI HOLLOW FIBER KIDNEYS, EXCEL
K833150 · KOC
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 61d
Cleared Nov 14, 1983
FOAM HELMET - USE W/ESOPHAGEAL TAMPONA
K832859 · KNT
Inmed Corp.
Gastroenterology & Urology · 83d
Cleared Nov 14, 1983
MUTO BRUSH
K833330 · FDX
Microvasive
Gastroenterology & Urology · 48d
Cleared Nov 14, 1983
ASPIRATION & IRRIGATION CATHETER
K833331 · OCX
Microvasive
Gastroenterology & Urology · 48d
Cleared Nov 07, 1983
C-FLEX PENROSE DRAINAGE TUBE
K833061 · FFA
Concept, Inc.
Gastroenterology & Urology · 59d
Cleared Nov 03, 1983
HEMO-DIAL
K832866 · KPO
Cmi Pharmaceuticals, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 31, 1983
MOTILITY MEASUREMENT SYS MMS-100
K832869 · FFX
Narco Bio-Systems
Gastroenterology & Urology · 68d
Cleared Oct 31, 1983
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · KNT
Abbott Laboratories
Gastroenterology & Urology · 60d
Cleared Oct 31, 1983
HOBBS MEDICAL GRASPING FORCEPS
K833125 · OCZ
Hobbs Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Oct 31, 1983
SECURITY STRETCH BRIEF-MEDICAL
K833245 · KNX
Mb Products, Ltd.
Gastroenterology & Urology · 48d