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
4729–4752 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 14, 1998
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
K974040 · FHA
Timm Research Co.
Gastroenterology & Urology · 263d
Cleared Jul 10, 1998
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 210d
Cleared Jul 08, 1998
ODYSSEY INSTRUMENTATION SYSTEM
K981294 · FIZ
Automata Instrumentation, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 08, 1998
SPEED-CUT AUTOMATIC BIOPSY SYSTEM
K981301 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 90d
Cleared Jul 08, 1998
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY...
K981612 · EZL
Rochester Medical Corp.
Gastroenterology & Urology · 63d
Cleared Jul 08, 1998
KSEA UROPUMP
K981615 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 07, 1998
PERCUTANEOUS BREAST BIOPSY (PBB)
K972328 · KNW
Urothealth System, Inc.
Gastroenterology & Urology · 379d
Cleared Jul 07, 1998
ANU ICE
K981428 · LKX
Cryoptherapy Pain Relief Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 29, 1998
DAUM BONE BIOPSY SET
K981320 · KNW
Daum Corp.
Gastroenterology & Urology · 80d
Cleared Jun 26, 1998
DIALOG DIALYSIS MACHINE
K963440 · KDI
B. Braun Medical AG
Gastroenterology & Urology · 665d
Cleared Jun 26, 1998
CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
K964514 · FKO
Corpak, Inc.
Gastroenterology & Urology · 605d
Cleared Jun 25, 1998
VED VALU- VACUUM ERECTION DEVICE
K980948 · LKY
Mission Pharmacal Comp
Gastroenterology & Urology · 104d
Cleared Jun 25, 1998
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE...
K981506 · LKY
Repro-Med Systems, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 22, 1998
KSEA CALCUSON
K973251 · FEO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 297d
Cleared Jun 22, 1998
ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018,...
K981166 · KNW
Inrad
Gastroenterology & Urology · 83d
Cleared Jun 19, 1998
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
K981286 · KDH
Armm, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 16, 1998
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
K981003 · KPO
International Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 15, 1998
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
K980980 · FFX
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 15, 1998
KSEA CALCUSPLIT
K981233 · FFK
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 73d
Cleared Jun 12, 1998
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
K973096 · KPI
Neotonus, Inc.
Gastroenterology & Urology · 297d
Cleared Jun 11, 1998
DRYALYSATE CONCENTRATE
K980659 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 111d
Cleared Jun 11, 1998
BODYSTAT DUALSCAN 2005
K980971 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 87d
Cleared Jun 10, 1998
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE
K981477 · KNW
Medical Biopsy, Inc.
Gastroenterology & Urology · 47d
Cleared Jun 09, 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653 · FGE
Cordis Corp.
Gastroenterology & Urology · 118d