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
7945–7968 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 10, 1986
UMS-100
K853683 · FAP
Narco Bio-Systems
Gastroenterology & Urology · 128d
Cleared Jan 10, 1986
NIR LAT MALE EXTERNAL CATHETER
K855209 · KNX
Mali, Inc.
Gastroenterology & Urology · 11d
Cleared Jan 09, 1986
ACUTE PERITONEAL DIALYSIS CATHETERS
K854966 · FKO
Thermedics, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · FJG
Gambro, Inc.
Gastroenterology & Urology · 149d
Cleared Jan 08, 1986
HEMODIALYSIS CONCENTRATE
K854391 · FKQ
Dana Laboratories
Gastroenterology & Urology · 69d
Cleared Jan 08, 1986
O'NEIL URINARY CATHETER INTRODUCER
K854443 · KOD
Pennine Medical , Ltd.
Gastroenterology & Urology · 64d
Cleared Jan 08, 1986
PLUME Y SET
K854951 · FIE
Hospal Medical Corp.
Gastroenterology & Urology · 29d
Cleared Jan 08, 1986
COLOSHIELD KIT
K855121 · KNT
Deknatel, Inc.
Gastroenterology & Urology · 16d
Cleared Jan 03, 1986
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
K854612 · LFK
Med-West, Inc.
Gastroenterology & Urology · 46d
Cleared Dec 19, 1985
LONG TERM PERITONEAL CATHETER
K854614 · FJS
Thermadics, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 17, 1985
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 228d
Cleared Dec 17, 1985
ZIMMON BILIARY STENT SET
K851962 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 228d
Cleared Dec 16, 1985
HD-SECURA HEMADIALYSIS MACHINE
K854367 · FKP
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Dec 16, 1985
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH
K854479 · FKP
Nipro Company, Ltd.
Gastroenterology & Urology · 39d
Cleared Dec 13, 1985
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 51d
Cleared Dec 13, 1985
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · KDI
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 13, 1985
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · KNX
Coloplast A/S
Gastroenterology & Urology · 28d
Cleared Dec 13, 1985
HOLLOW FIBER DIALYZER
K854586 · KDI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 25d
Cleared Dec 02, 1985
FOUR CHANNEL PH PROBE
K853280 · FFT
Akron City Hospital
Gastroenterology & Urology · 119d
Cleared Dec 02, 1985
VISTA MED-URISTAT
K853892 · KNX
Vista Med
Gastroenterology & Urology · 74d
Cleared Dec 02, 1985
1351 UROFLOW AUTO START
K853936 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Dec 02, 1985
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
K854027 · LNK
Laserscope
Gastroenterology & Urology · 62d
Cleared Dec 02, 1985
DYNAFEED
K854215 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 46d
Cleared Dec 02, 1985
DEPEND FITTED BRIEF
K854378 · EYQ
Kimberly-Clark Corp.
Gastroenterology & Urology · 33d