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
4417–4440 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 18, 2000
A-22 HEMODIALYZER
K992563 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-180 HEMODIALYZER
K992564 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-150 HEMODIALYZER
K992566 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
AF-220 HEMODIALYZER
K992573 · KDI
Althin Medical AB
Gastroenterology & Urology · 169d
Cleared Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · KNQ
Cordis Corp.
Gastroenterology & Urology · 76d
Cleared Jan 14, 2000
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991916 · FIP
Virginia Water Systems, Inc.
Gastroenterology & Urology · 221d
Cleared Jan 12, 2000
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
K992719 · KNT
Amsino Intl., Inc.
Gastroenterology & Urology · 153d
Cleared Jan 12, 2000
LEMAITRE BILIARY CATHETER
K992941 · LQR
Vascutech, Inc.
Gastroenterology & Urology · 134d
Cleared Jan 10, 2000
AMUKIN D
K992016 · LIF
Amuchina Intl., Inc.
Gastroenterology & Urology · 209d
Cleared Jan 10, 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL...
K993411 · HIR
Mega Electronics , Ltd.
Gastroenterology & Urology · 90d
Cleared Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT,...
K994156 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 07, 2000
AUTOMATED CORE BIOPSY DEVICE
K994272 · KNW
Promex, Inc.
Gastroenterology & Urology · 18d
Cleared Jan 06, 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
K990803 · FIE
Medisystems Corp.
Gastroenterology & Urology · 302d
Cleared Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
K993392 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 06, 2000
DISPOS-A-SCOPE
K993738 · FER
Dispos-A-Scope
Gastroenterology & Urology · 63d
Cleared Jan 06, 2000
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · OCX
Northgate Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE...
K993892 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 51d
Cleared Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 94d
Cleared Dec 28, 1999
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · FED
Applied Medical Resources
Gastroenterology & Urology · 60d
Cleared Dec 27, 1999
ELITE CUSTOM
K993142 · LKY
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
VITALITY SYSTEM
K993143 · LKY
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE,...
K993936 · KNW
Imagyn Surgical
Gastroenterology & Urology · 38d
Cleared Dec 27, 1999
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
K994166 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 18d