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
6721–6744 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 07, 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
K903813 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 79d
Cleared Nov 05, 1990
NELATON-, FEMALE - OR TIEMANN CATHETER
K896729 · KOD
Unoplast A/S
Gastroenterology & Urology · 340d
Cleared Nov 05, 1990
GASTROGRAPH
K903646 · FFT
Medics Instrument Corp.
Gastroenterology & Urology · 83d
Cleared Nov 02, 1990
FRESENIUS AS 104 CELL SEPARATOR
K895435 · LKN
Fresenius USA, Inc.
Gastroenterology & Urology · 421d
Cleared Nov 02, 1990
UNOMETER 500
K896732 · EXR
Unoplast A/S
Gastroenterology & Urology · 337d
Cleared Nov 02, 1990
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371 · FAE
Mentor Corp.
Gastroenterology & Urology · 280d
Cleared Nov 01, 1990
AMICON DIAFILTER 30 HEMOCONCENTRATOR
K902837 · KDI
Amicon, Inc.
Gastroenterology & Urology · 126d
Cleared Oct 31, 1990
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
K903816 · EZK
Respiratory Support Products, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 30, 1990
FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
K902149 · FKX
Fresenius/Delmed, Inc.
Gastroenterology & Urology · 168d
Cleared Oct 26, 1990
ZIMMON ENDOSCOPIC PANCREATIC STENT
K900923 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 241d
Cleared Oct 26, 1990
ETUDE, URODYNAMIC INVESTIGATION SYSTEM
K901494 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 26, 1990
SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536
K901922 · EXN
Safte S.P.A.
Gastroenterology & Urology · 179d
Cleared Oct 26, 1990
PRECISION OPTICS ENDOSCOPE ADAPTER
K903459 · FET
Precise Optics
Gastroenterology & Urology · 86d
Cleared Oct 26, 1990
ILC LEG BAG HOLDER
K903611 · FAQ
Inman Liebelt Corp.
Gastroenterology & Urology · 78d
Cleared Oct 23, 1990
DEODORIZING AND SOUND MUFFLING ANAL PAD
K903342 · EYQ
Biological Resistance, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 22, 1990
SOEHENDRA STENT RETRIEVER
K903420 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 22, 1990
LIFECOIL CATHETER
K903502 · FJS
Lifemed of California
Gastroenterology & Urology · 80d
Cleared Oct 19, 1990
AMUKIN 50% - AIRSPRAY(R)
K885037 · FKO
Bernard J. Cooney, P.A.
Gastroenterology & Urology · 683d
Cleared Oct 19, 1990
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
K903457 · FET
Precise Optics
Gastroenterology & Urology · 79d
Cleared Oct 19, 1990
PRECISION OPTICS IMAGE COUPLER
K903458 · FET
Precise Optics
Gastroenterology & Urology · 79d
Cleared Oct 19, 1990
URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
K903994 · FGF
Applied Urology, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 17, 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 75d
Cleared Oct 15, 1990
WILSON-COOK ASPIRATION HANDLE
K903668 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 63d