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
5785–5808 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 01, 1994
RIMECO MIDSTREAM URINE COLLECTOR
K943752 · FOC
Rimeco Products, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 01, 1994
LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
K944688 · FFS
Progressive Dynamics, Inc.
Gastroenterology & Urology · 40d
Cleared Oct 28, 1994
CAMERA COVER WITH TEAR TIP
K940152 · FEM
Hydro-Med Products, Inc.
Gastroenterology & Urology · 298d
Cleared Oct 20, 1994
INFLATABLE RETENTION CUFF SPECULUM
K941391 · GBT
Innovatec Medical Corp.
Gastroenterology & Urology · 212d
Cleared Oct 17, 1994
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 896d
Cleared Oct 14, 1994
MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
K944837 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 13, 1994
GALILEO ENDOSCOPES
K934649 · FBO
Galileo Electro-Optics Corp.
Gastroenterology & Urology · 379d
Cleared Oct 13, 1994
GLASSMAN SILICONE CATHETER
K934895 · EZL
Axiom Medical, Inc.
Gastroenterology & Urology · 373d
Cleared Oct 13, 1994
INJECT-SNARE
K942110 · FDI
Endovations
Gastroenterology & Urology · 164d
Cleared Oct 13, 1994
LSVP INTERNATIONAL BIOPSY FORCEPS
K944770 · FCL
Lsvp Intl., Inc.
Gastroenterology & Urology · 16d
Cleared Oct 13, 1994
CATCO UROLOGICAL CATHETER
K944782 · EZD
Catco Medical, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 11, 1994
OXYGEN MOUTHGUARD
K944049 · MNK
Endovations, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 07, 1994
SILICONE CATHETER REPAIR KITS
K926374 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 654d
Cleared Oct 07, 1994
NORTA
K935630 · EZL
Beiersdorf, Inc.
Gastroenterology & Urology · 318d
Cleared Oct 07, 1994
AMPLATZ SUPER STIFF GUIDEWIRE
K944754 · KNY
Boston Scientific Corp
Gastroenterology & Urology · 11d
Cleared Oct 05, 1994
URETERAL ILLUMINATOR
K941506 · FCS
Apple Medical Corp.
Gastroenterology & Urology · 190d
Cleared Oct 03, 1994
WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
K940396 · ESW
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 249d
Cleared Sep 30, 1994
BIOLOGIC DT-1000 MACHINE
K923046 · KNT
Hemocleanse, Inc.
Gastroenterology & Urology · 828d
Cleared Sep 30, 1994
WALLSTENT BILIARY ENDOPROTHESES
K923993 · FGE
Schneider U.S. Stent Div.
Gastroenterology & Urology · 781d
Cleared Sep 30, 1994
ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.
K925405 · FFT
Synectics-Dantec
Gastroenterology & Urology · 704d
Cleared Sep 30, 1994
CENTRYSYSTEM 3 WITH CHARTS/BP OPTION
K925522 · KOC
C.G.H. Medical, Inc.
Gastroenterology & Urology · 697d
Cleared Sep 30, 1994
BAXTER CT DIALYZER
K926568 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 638d
Cleared Sep 30, 1994
NO-MES
K935633 · KNT
Ethox Corp.
Gastroenterology & Urology · 311d
Cleared Sep 30, 1994
WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE
K941958 · KPO
Western Dialysis Supplies , Ltd.
Gastroenterology & Urology · 161d