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
2449–2472 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 29, 2011
SURECORE BIOPSY DEVICE
K102756 · KNW
Chest Innovations, Inc.
Gastroenterology & Urology · 432d
Cleared Nov 21, 2011
CHIBA SONO
K113209 · KNW
Pajunk GmbH
Gastroenterology & Urology · 21d
Cleared Nov 18, 2011
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
K102833 · MPB
Foshan Nanhai Bai HE Medical...
Gastroenterology & Urology · 415d
Cleared Nov 08, 2011
ENTERAL FEEDING BAG AND SETS
K102741 · KNT
Shandong Weigao Group Medical Polymer...
Gastroenterology & Urology · 412d
Cleared Nov 04, 2011
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
K100811 · OBH
ImpediMed Limited
Gastroenterology & Urology · 592d
Cleared Nov 03, 2011
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
K111648 · FCX
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 143d
Cleared Nov 03, 2011
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20,...
K112945 · KNW
Inrad, Inc.
Gastroenterology & Urology · 30d
Cleared Nov 01, 2011
TRANSTEK
K112932 · MNW
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 01, 2011
BODY ANALYSIS SCALE
K112951 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 28d
Cleared Oct 28, 2011
SUMO ACCESS AND TISSUE RESECTION SYSTEM
K103155 · ODC
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 367d
Cleared Oct 27, 2011
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
K112178 · FIE
JMS North America Corporation
Gastroenterology & Urology · 91d
Cleared Oct 25, 2011
CHARGER BALLOON DILATATION CATHETER
K112701 · FGE
Boston Scientific
Gastroenterology & Urology · 39d
Cleared Oct 24, 2011
WINGEATER V2
K111948 · FIE
JMS North America Corporation
Gastroenterology & Urology · 108d
Cleared Oct 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K111639 · KDI
Fresenius Medical Care
Gastroenterology & Urology · 130d
Cleared Oct 20, 2011
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
K112468 · KNW
Regulatory Specialists, Inc.
Gastroenterology & Urology · 55d
Cleared Oct 19, 2011
AMT G-J TUBE
K110804 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 19, 2011
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY...
K111766 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 118d
Cleared Oct 13, 2011
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163 · FPD
Vygon Corp.
Gastroenterology & Urology · 631d
Cleared Oct 07, 2011
HUIBAO BODY FAT SCALE
K111404 · MNW
Zhongshan Huibao Weighing Apparatus...
Gastroenterology & Urology · 141d
Cleared Oct 06, 2011
ENDOFLIP ECD
K110531 · FED
Crospon, Ltd.
Gastroenterology & Urology · 224d
Cleared Oct 05, 2011
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K111740 · FIP
Ameriwater
Gastroenterology & Urology · 106d
Cleared Sep 30, 2011
DESARA MESH
K112609 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 29, 2011
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
K112434 · KNT
Bd Medical Surgical
Gastroenterology & Urology · 36d
Cleared Sep 28, 2011
LITE-MED LM-9200 ELMA
K103217 · LNS
Lite-Med, Inc.
Gastroenterology & Urology · 331d