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
4153–4176 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 22, 2001
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 318d
Cleared Jun 22, 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
K003877 · FIP
Mar Cor Services, Inc.
Gastroenterology & Urology · 189d
Cleared Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 2001
TAUT BALLOON CATHETER, MODEL 50640
K011018 · GCA
Taut, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 2001
AUTOMATED CORE BIOPSY DEVICE
K011270 · FCG
Promex, Inc.
Gastroenterology & Urology · 57d
Cleared Jun 22, 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · KPI
Hmt, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 22, 2001
DORNIER LITHOTRIPTER 140(DOLI 140)
K011773 · LNS
Dornier
Gastroenterology & Urology · 15d
Cleared Jun 21, 2001
MEDCOMP ASH SPLIT
K011576 · NFK
Medical Components, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
K011148 · FJI
Interpore Cross Intl.
Gastroenterology & Urology · 58d
Cleared Jun 12, 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 242d
Cleared Jun 11, 2001
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
K010760 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 08, 2001
MAR COR SERVICES BICARB SYSTEM
K003560 · FIN
Mar Cor Services, Inc.
Gastroenterology & Urology · 203d
Cleared Jun 06, 2001
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
K011055 · FCM
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 61d
Cleared Jun 04, 2001
CONTINUOUS FLOW Y-TUBING
K010122 · LJH
G.U.-Tek
Gastroenterology & Urology · 139d
Cleared Jun 04, 2001
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
K010667 · KDI
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jun 01, 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 58d
Cleared May 31, 2001
OSTEOBELL
K011104 · KNW
Biopsybell S.A.S.
Gastroenterology & Urology · 50d
Cleared May 24, 2001
HEMODIALYSIS TUBING SETS
K001971 · FIB
Ofi Biomedica S.P.A.
Gastroenterology & Urology · 330d
Cleared May 21, 2001
PELVEX HOMETRAINER
K002043 · HIR
Purdue Technology Park
Gastroenterology & Urology · 320d
Cleared May 16, 2001
MODIFICATION TO MALE TO MALE LUER ADAPTER
K003712 · KOC
Molded Products, Inc.
Gastroenterology & Urology · 166d
Cleared May 16, 2001
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
K010448 · FBK
Horizons Intl. Corp.
Gastroenterology & Urology · 90d
Cleared May 15, 2001
DISPOSABLE BENDING CANNULA PR-233Q
K011149 · ODD
The Olympus Optical Co.
Gastroenterology & Urology · 29d
Cleared May 15, 2001
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
K011151 · FDS
The Olympus Optical Co.
Gastroenterology & Urology · 29d