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
6601–6624 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 09, 1991
HAEMODIALYSIS CONCENTRATE
K904946 · KPO
Bdh, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1991
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · OCX
C.R. Bard, Inc.
Gastroenterology & Urology · 147d
Cleared Apr 09, 1991
FORMASURE TEST REAGENT
K905217 · LIF
Di-Chem, Inc.
Gastroenterology & Urology · 140d
Cleared Apr 09, 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · FAD
Vas-Cath, Inc.
Gastroenterology & Urology · 137d
Cleared Apr 09, 1991
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
K910215 · FKP
Cd Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 09, 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · KDI
Minntech Corp.
Gastroenterology & Urology · 81d
Cleared Apr 08, 1991
LAPAROMED CHOLANGIOGRAM DEVICE
K910219 · FGE
Laparomed Corp.
Gastroenterology & Urology · 81d
Cleared Apr 02, 1991
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · LIF
Serim Research Corp.
Gastroenterology & Urology · 320d
Cleared Apr 02, 1991
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
K910022 · FCM
Medical Marketing Group
Gastroenterology & Urology · 89d
Cleared Apr 02, 1991
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
K910217 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 02, 1991
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
K910285 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 02, 1991
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
K910497 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 02, 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 01, 1991
CLEANFLOW SYSTEM
K910728 · KQT
Mitron Technologies, Inc.
Gastroenterology & Urology · 40d
Cleared Mar 29, 1991
ORIGINEEDLE(TM)
K904849 · FHO
Origin Medsystems, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 28, 1991
AVD INTIMAX CHOLANGIOGRAPHY CATHETER
K910493 · FGE
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 27, 1991
CHF-B20 CHOLEDOCHOSCOPE
K904799 · FBN
Olympus Corp.
Gastroenterology & Urology · 154d
Cleared Mar 27, 1991
SIF-SW
K904800 · FDA
Olympus Corp.
Gastroenterology & Urology · 154d
Cleared Mar 27, 1991
BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
K910196 · FGH
C.R. Bard, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 22, 1991
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
K900105 · LKN
Cobe Laboratories, Inc.
Gastroenterology & Urology · 437d
Cleared Mar 21, 1991
IE MAGNETIC EXTRACTOR
K904668 · FCC
Olympus Corp.
Gastroenterology & Urology · 157d
Cleared Mar 21, 1991
OPERATIVE CHOLANGIOGRAPHIC CATHETER
K905738 · FGE
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 21, 1991
450CM GUIDE WIRE FOR G.I. USE
K910722 · OCY
Terumo Corp.
Gastroenterology & Urology · 29d
Cleared Mar 19, 1991
BCI-100 FECAL INCONTINENCE SYSTEM
K904646 · FAP
Biocare Intl.
Gastroenterology & Urology · 159d