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
3577–3600 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 20, 2004
PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER
K033676 · MSD
Kendall
Gastroenterology & Urology · 88d
Cleared Feb 20, 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 20, 2004
WILSON-COOK USW CAP AND WIRE LOCK
K040137 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 20, 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 17, 2004
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
K032958 · LNS
United Medical Systems, Inc.
Gastroenterology & Urology · 148d
Cleared Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · FGE
Abbott Laboratories
Gastroenterology & Urology · 62d
Cleared Feb 17, 2004
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K040248 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 14d
Cleared Feb 13, 2004
CANNON II PLUS
K040078 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 05, 2004
MOSSMED DUAL INTERMITTENT ASPIRATOR
K031492 · KNT
Moss Medical Products
Gastroenterology & Urology · 269d
Cleared Feb 04, 2004
AMSURE RED RUBBER URETHRAL CATHETER
K030293 · EYB
Amsino International, Inc.
Gastroenterology & Urology · 372d
Cleared Feb 04, 2004
DURAMAX .018 BILIARY STENT SYSTEM
K032436 · FGE
Avantec Vascular Corp.
Gastroenterology & Urology · 181d
Cleared Feb 04, 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
K033497 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 04, 2004
BARD TIGERTAIL URETERAL CATHETER
K033719 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 70d
Cleared Jan 30, 2004
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · FGB
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 71d
Cleared Jan 30, 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Jan 28, 2004
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
K031167 · MNW
Idt Technology Limited
Gastroenterology & Urology · 289d
Cleared Jan 16, 2004
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
K031617 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 238d
Cleared Jan 15, 2004
REMEEX SYSTEM FOR URINARY INCONTINENCE
K033310 · OTN
Specialities Remeex International, S.L.
Gastroenterology & Urology · 93d
Cleared Jan 14, 2004
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · KNQ
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared Jan 12, 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · KNQ
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 277d
Cleared Jan 09, 2004
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
K032710 · KOD
Apogee Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Jan 09, 2004
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218
K033830 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 02, 2004
OMNILINK .018 BILIARY STENT SYSTEM
K033834 · FGE
Guidant Corp.
Gastroenterology & Urology · 23d
Cleared Dec 30, 2003
HEMEDEX FIXATION DEVICE
K032127 · KNY
Hemedex Incorporated
Gastroenterology & Urology · 173d