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
5473–5496 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 24, 1995
AQUISEN
K952583 · LJH
Aquintel, Inc.
Gastroenterology & Urology · 80d
Cleared Aug 18, 1995
THE ASSISTANT
K952841 · FHA
Apple Medical Corp.
Gastroenterology & Urology · 58d
Cleared Aug 18, 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K952887 · LJE
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 56d
Cleared Aug 18, 1995
ADI CATHETER WITH VALVE
K952924 · GBM
Asia Dynamics, Inc.
Gastroenterology & Urology · 53d
Cleared Aug 18, 1995
LINDNER/GOLOMB SP INTRODUCING SOUND
K953024 · KOB
Cook Urological, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 18, 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232 · KNT
Hollister, Inc.
Gastroenterology & Urology · 39d
Cleared Aug 18, 1995
RIZA-RIBE NEEDLE
K953441 · FBK
R-Med, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 16, 1995
ULTRATHIN URETEROSCOPES
K951855 · FGB
Olympus America, Inc.
Gastroenterology & Urology · 117d
Cleared Aug 15, 1995
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
K943801 · FCS
Rocket of London, Ltd.
Gastroenterology & Urology · 377d
Cleared Aug 15, 1995
RMI HEMOCONCENTRATOR
K951344 · KDI
Research Medical, Inc.
Gastroenterology & Urology · 144d
Cleared Aug 15, 1995
PROSYS LEG BAG
K952208 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 97d
Cleared Aug 10, 1995
DILATATION CATHETER, BALLOON
K952968 · LJE
Boston Scientific Corp
Gastroenterology & Urology · 44d
Cleared Aug 09, 1995
PERIPUMP
K934552 · HIR
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 687d
Cleared Aug 09, 1995
SERIM HISENSE TEST KIT
K952215 · FIP
Serim Research Corp.
Gastroenterology & Urology · 90d
Cleared Aug 07, 1995
ZEROID HEMORRHOIDAL DEVICE
K944874 · LKX
Medical Appliance Research Corp.
Gastroenterology & Urology · 308d
Cleared Aug 04, 1995
URINARY DRAINAGE BAG
K951597 · EYZ
Key Medical Services, Inc.
Gastroenterology & Urology · 119d
Cleared Aug 02, 1995
ABSORBALBE ANCHOR
K944051 · MNV
Mitek Surgical Products, Inc.
Gastroenterology & Urology · 348d
Cleared Aug 02, 1995
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
K946080 · FCO
Portable Power Systems, Inc.
Gastroenterology & Urology · 232d
Cleared Aug 02, 1995
IMAGYN UROSCOPE
K953201 · FAJ
Imagyn Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 02, 1995
INJECTION NEEDLE
K953338 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 16d
Cleared Aug 01, 1995
VIDEO SIGMOIDOSCOPE
K950429 · FAM
Welch Allyn, Inc.
Gastroenterology & Urology · 180d
Cleared Jul 31, 1995
WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
K952691 · FJC
Welch Allyn, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 27, 1995
COLD LIGHT SOURCE LOS XL-A 100
K952028 · GCT
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 87d
Cleared Jul 25, 1995
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE
K952187 · KOB
Rusch, Inc.
Gastroenterology & Urology · 77d