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
3121–3144 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 31, 2007
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K070129 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 15d
Cleared Jan 30, 2007
GAMBRO QUICKSET BLOODLINES
K063290 · FJK
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jan 29, 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24,...
K063431 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 17, 2007
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 111d
Cleared Jan 12, 2007
TRU-CABLE
K063309 · FFS
Truphatek International, Ltd.
Gastroenterology & Urology · 71d
Cleared Jan 12, 2007
NIPRO SAFETOUCH II GAMMA
K063721 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 28d
Cleared Jan 09, 2007
XODUS MEDICAL ANTI-FOG SOLUTION
K063587 · OCT
Xodus Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Jan 05, 2007
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632 · LJE
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 05, 2007
FUSION QUATTRO EXTRACTION BALLOON XL
K063677 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 25d
Cleared Jan 04, 2007
GAMBRO POSICLEAR
K061782 · FIP
Gambro Services, Inc.
Gastroenterology & Urology · 192d
Cleared Dec 28, 2006
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
K062652 · MNW
Tanita Corporation of America
Gastroenterology & Urology · 112d
Cleared Dec 27, 2006
RIGIDOMETER, MODEL DIR-4U
K061676 · LIL
Uroan 21
Gastroenterology & Urology · 196d
Cleared Dec 22, 2006
LITHODIAMOND ULTRA
K061350 · LNS
Pck Electronic Industry & Trade Co.,...
Gastroenterology & Urology · 221d
Cleared Dec 22, 2006
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · KGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 116d
Cleared Dec 19, 2006
NEEDLELESS SLING
K063136 · PAH
Specialities Remeex International, S.L.
Gastroenterology & Urology · 64d
Cleared Dec 15, 2006
NEXUS IRRIGATION TUBING SET
K062551 · LJH
Nexus Medical, LLC
Gastroenterology & Urology · 107d
Cleared Dec 15, 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 13, 2006
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
K062922 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 76d
Cleared Dec 12, 2006
CYSTOGLIDE INTRODUCER SHEATH
K052298 · KNY
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 476d
Cleared Dec 08, 2006
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
K062707 · FGB
Innovative Endoscopy Components, LLC
Gastroenterology & Urology · 88d
Cleared Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
K062435 · NFK
Spire Biomedical, Inc.
Gastroenterology & Urology · 106d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS...
K062750 · MUM
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Dec 01, 2006
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K061937 · KNQ
Cook Endoscopy
Gastroenterology & Urology · 144d
Cleared Nov 30, 2006
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
K062833 · FCF
Vidacare Corporation
Gastroenterology & Urology · 70d