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
9529–9552 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 15, 1979
DAP-PAK
K781755 · KDJ
Dravon Medical, Inc.
Gastroenterology & Urology · 121d
Cleared Feb 08, 1979
BK-6021 CONDOM CATHETER HOLDER
K790174 · KNX
Fred Sammons, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 01, 1979
PANT LINER, DISP. INCONTINENT
K781930 · EYQ
Fibre Formations, Inc.
Gastroenterology & Urology · 78d
Cleared Jan 22, 1979
CATHETER, AKRON FOLEY TEFLON
K781751 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 98d
Cleared Jan 17, 1979
DIALYSATE DELIVERY SYSTEM
K781886 · FKP
Cordis Corp.
Gastroenterology & Urology · 71d
Cleared Jan 17, 1979
ADMINISTRATION SET, ENEMA
K790005 · FCE
Kelsar Corp.
Gastroenterology & Urology · 15d
Cleared Jan 10, 1979
C-CORD
K782046 · FFZ
Concept, Inc.
Gastroenterology & Urology · 33d
Cleared Jan 03, 1979
VAGATEX
K782083 · HIR
Vagatex
Gastroenterology & Urology · 20d
Cleared Dec 20, 1978
CORTRAL I
K780527 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 261d
Cleared Dec 20, 1978
HEMODIALYZER, MODEL RP610, RP AN 69
K781464 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 117d
Cleared Dec 15, 1978
SUPER-SORBER
K780938 · EYQ
Home Healthcare Products, Inc.
Gastroenterology & Urology · 190d
Cleared Dec 15, 1978
AQUA-GEL
K781032 · EXQ
Murray, Salk, Inc.
Gastroenterology & Urology · 179d
Cleared Dec 15, 1978
DIALYZER, PARALLEL FLOW DISPOSABLE
K781795 · FJG
Medical, Inc.
Gastroenterology & Urology · 51d
Cleared Dec 07, 1978
SUITCASE KIDNEY HEMODIALYSIS SYSTEM
K781405 · FKP
Union Carbide Corp.
Gastroenterology & Urology · 115d
Cleared Dec 07, 1978
ULTRAFILTRATION SCALE
K781633 · FIL
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 77d
Cleared Dec 07, 1978
SURGITEK DOUBLE J URETEROL STENT
K781641 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 77d
Cleared Dec 07, 1978
CATHETER, EXTERNAL MALE NURSING CARE
K781780 · KNX
Medi-Tech, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 07, 1978
HEMODIALYSIS CONCENTRATE, SODIU
K781967 · KPO
Renal Systems, Inc.
Gastroenterology & Urology · 13d
Cleared Dec 04, 1978
TUBING, AXIOM SILICONE PENROSE
K781749 · KDH
Axiom Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 04, 1978
URINARY DRAINAGE BAG
K781987 · KNY
Kelsar Corp.
Gastroenterology & Urology · 10d
Cleared Nov 22, 1978
CUTTER RESIFLEX URINE METER
K781521 · KNX
Cutter Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared Nov 03, 1978
AKRON MALE EXTERNAL CATHETER
K781433 · KNX
Latex Ind., Inc.
Gastroenterology & Urology · 74d
Cleared Nov 03, 1978
DISC, COLOPLAST PRE-OP STOMA
K781736 · EXA
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared Oct 24, 1978
CENTRAL CATHETER TRAY
K781333 · KGC
Argon Medical Corp.
Gastroenterology & Urology · 83d