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
3745–3768 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 20, 2003
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES,...
K030497 · KPO
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared May 20, 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
K030502 · MSD
Medcomp
Gastroenterology & Urology · 90d
Cleared May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295 · PAG
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared May 13, 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · MNW
Biospace Co.,Ltd
Gastroenterology & Urology · 209d
Cleared May 13, 2003
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
K030209 · MPB
The Kendall Company
Gastroenterology & Urology · 112d
Cleared May 09, 2003
DIATEK CANNON-CATHETER, MODEL CC5500
K022662 · MSD
Arrow Intl., Inc.
Gastroenterology & Urology · 273d
Cleared May 09, 2003
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
K030443 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 87d
Cleared May 06, 2003
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
K023615 · MSF
Gambro Renal Products
Gastroenterology & Urology · 190d
Cleared May 06, 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
K031186 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared May 02, 2003
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K030346 · LNS
Fmd, LLC
Gastroenterology & Urology · 88d
Cleared May 02, 2003
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945...
K030349 · MNW
Bonso Electronics International, Inc.
Gastroenterology & Urology · 88d
Cleared Apr 30, 2003
HEMO-STREAM HEMODIALYSIS CATHETER SET
K023847 · MSD
Rex Medical
Gastroenterology & Urology · 162d
Cleared Apr 30, 2003
ATHENA PELVIC MUSCLE TRAINER
K023905 · KPI
Athena Feminine Technologies, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 30, 2003
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
K030451 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR...
K030983 · MSD
Deltec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 22, 2003
VITALCARE URETHRAL CATHETER
K021938 · GBM
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
VITALCARE FOLEY CATHETER
K021939 · EZL
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 21, 2003
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
K030203 · MNW
Long Well Electronics Corp.
Gastroenterology & Urology · 90d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
K030855 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Apr 16, 2003
PANCREATIC DRAINAGE TUBE
K021672 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 330d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 14, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
K023308 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 193d