FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Gastroenterology & Urology ×
9,917 results
4705–4728 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 10, 1998
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
K983187 · KNW
Medsol Corp.
Gastroenterology & Urology · 90d
Cleared Dec 07, 1998
MICRO X RESIDUAL TEST STRIPS
K974064 · MSY
Reprocessing Products Corp
Gastroenterology & Urology · 406d
Cleared Dec 04, 1998
RAPPORT V.T.D.
K982275 · LKY
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d
Cleared Dec 01, 1998
DELIVERY SHEATH
K983415 · FED
Conway Stuart Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Nov 25, 1998
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
K981365 · MSD
Sherwood Medical Co.
Gastroenterology & Urology · 224d
Cleared Nov 25, 1998
PERIPHERAL AVE STENT SYSTEM
K983008 · FGE
Peripheral Ave
Gastroenterology & Urology · 89d
Cleared Nov 25, 1998
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076 · FIB
Medisystems Corp.
Gastroenterology & Urology · 84d
Cleared Nov 24, 1998
ERCO-RIBBON
K981343 · LKY
Ercons, Inc.
Gastroenterology & Urology · 225d
Cleared Nov 24, 1998
ERCO-VAC
K981357 · LKY
Ercons, Inc.
Gastroenterology & Urology · 224d
Cleared Nov 24, 1998
IN-PROBE II URODYNAMIC SYSTEM
K983325 · FEN
Influence, Inc.
Gastroenterology & Urology · 63d
Cleared Nov 20, 1998
PERIFORM
K981277 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 226d
Cleared Nov 17, 1998
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
K980492 · FFK
Circon Acmi
Gastroenterology & Urology · 281d
Cleared Nov 16, 1998
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K980182 · FIP
Usfilter/Ionpure, Inc.
Gastroenterology & Urology · 300d
Cleared Nov 13, 1998
NIR BILIARY STENT
K973171 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 445d
Cleared Nov 13, 1998
HEMOCOR HPH 700 HEMOCONCENTRATOR
K983085 · KDI
Minntech Corp.
Gastroenterology & Urology · 71d
Cleared Nov 10, 1998
DIAPACT CRRT
K973322 · KDI
B.Braun Medical, Inc.
Gastroenterology & Urology · 432d
Cleared Nov 06, 1998
NATURALYTE, MODEL # 08-4004-1
K982813 · KPO
Kaybath, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 06, 1998
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
K983218 · FCG
Avid N.I.T., Inc.
Gastroenterology & Urology · 53d
Cleared Nov 04, 1998
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
K982760 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Nov 03, 1998
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
K983101 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 03, 1998
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · KPI
Empi
Gastroenterology & Urology · 50d
Cleared Nov 02, 1998
POS-T-VAC (AVP-1000)
K983245 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 02, 1998
POS-T-VAC (IVP-600)
K983246 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Oct 28, 1998
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K982970 · EZL
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 64d