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
2545–2568 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 01, 2011
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
K103647 · FER
Thd Spa
Gastroenterology & Urology · 78d
Cleared Feb 24, 2011
SINGLE USE BILIARY DRAINAGE STENT V
K103478 · FGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Feb 18, 2011
STEMPRO MSC SFM
K103302 · NDS
Life Technologies Corporation
Gastroenterology & Urology · 101d
Cleared Feb 15, 2011
SYSTEMS INTEGRATION
K102763 · ODA
Olympus Medical Systems Corporation
Gastroenterology & Urology · 144d
Cleared Feb 11, 2011
SYSLOC MINI V3
K110157 · FIE
JMS North America Corporation
Gastroenterology & Urology · 23d
Cleared Feb 10, 2011
REDSENSE-ALARM UNIT AND SENSOR
K103242 · ODX
Redsense Medical AB
Gastroenterology & Urology · 100d
Cleared Feb 10, 2011
VENOFER PUMP
K103564 · KDI
Renal Solutions, Inc.
Gastroenterology & Urology · 66d
Cleared Feb 07, 2011
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K082254 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 913d
Cleared Feb 07, 2011
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
K082255 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 913d
Cleared Feb 07, 2011
HAKKI URINARY CATHETER
K101900 · GBM
Hakki Medical Technologies, Inc.
Gastroenterology & Urology · 215d
Cleared Feb 03, 2011
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
K070049 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 1491d
Cleared Feb 03, 2011
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K102892 · FIP
Aqua Sciences, Inc.
Gastroenterology & Urology · 126d
Cleared Feb 01, 2011
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K102238 · MSD
Teleflexmedical, Inc.
Gastroenterology & Urology · 176d
Cleared Jan 31, 2011
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION...
K103254 · KNT
Coloplast A/S
Gastroenterology & Urology · 89d
Cleared Jan 26, 2011
STAYHEALTHY BODY COMPOSITION MONITOR-BCM
K101807 · MNW
Stayhealthy, Inc.
Gastroenterology & Urology · 212d
Cleared Jan 14, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 87d
Cleared Jan 14, 2011
MULTIPURPOSE DRAINAGE CATHETER
K103353 · FGE
Navilyst Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 14, 2011
G-PROX EZ ENDOSCOPIC GRASPER
K103688 · OCZ
Usgi Medical
Gastroenterology & Urology · 28d
Cleared Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030 · ODG
Boston Scientific Corp
Gastroenterology & Urology · 7d
Cleared Jan 11, 2011
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE...
K102781 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 106d
Cleared Jan 07, 2011
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH...
K101750 · MNV
Reprocessing Products Corp
Gastroenterology & Urology · 199d
Cleared Jan 07, 2011
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH
K103043 · EZD
Adapta Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jan 07, 2011
BACKSTOP CATHETER
K103349 · KOD
Pluromed, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 30, 2010
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
K102616 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 111d