FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145897–145920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1985
WIDEX MODEL M1
K853793 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 82d
Cleared Dec 02, 1985
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · FRN
Travenol Laboratories, S.A.
General Hospital · 74d
Cleared Dec 02, 1985
VISTA MED-URISTAT
K853892 · KNX
Vista Med
Gastroenterology & Urology · 74d
Cleared Dec 02, 1985
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
K853925 · JHI
Nms Pharmaceuticals, Inc.
Chemistry · 69d
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
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER
K854028 · JIW
Verified Medical Research, Inc.
Chemistry · 62d
Cleared Dec 02, 1985
DYNAFEED
K854215 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 46d
Cleared Dec 02, 1985
MAGNETIC RETRIEVER
K854281
Aspen Laboratories, Inc.
General & Plastic Surgery · 39d
Cleared Dec 02, 1985
DEPEND FITTED BRIEF
K854378 · EYQ
Kimberly-Clark Corp.
Gastroenterology & Urology · 33d
Cleared Dec 02, 1985
ROTEX SCREW BIOPSY NEEDLE
K854404 · FCG
Meadox Surgimed, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 02, 1985
MALIS IRRIGATION SYSTEM
K854413 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 28d
Cleared Dec 02, 1985
VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON
K854497 · IOR
Canadian Wheelchair
Physical Medicine · 20d
Cleared Dec 02, 1985
TUBING CLAMP CAT#1000-A
K854512 · FKK
Rao Medical Devices, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 02, 1985
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
K854517 · FKK
Travenol Laboratories, S.A.
Gastroenterology & Urology · 20d
Cleared Dec 02, 1985
BLADE, SCALPEL
K854561 · GES
Medelec Intl. Corp.
General & Plastic Surgery · 18d
Cleared Dec 02, 1985
V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
K854568 · GEF
American V. Mueller
General & Plastic Surgery · 18d
Cleared Dec 02, 1985
MODIFIED AM-SERIES DIALYZERS
K854575 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Nov 29, 1985
EDEC 2000
K852908 · IZO
Electromed Intl., Ltd.
Radiology · 143d
Cleared Nov 29, 1985
PO-510 TCPO2 MONITOR
K852959 · KLK
Sumitomo Electric Industries, Inc.
Anesthesiology · 140d
Cleared Nov 29, 1985
ELF
K853433 · BTY
Cardio-Respiratory
Anesthesiology · 106d
Cleared Nov 29, 1985
IN A WINK LUBRICATING & REWETTING DROPS
K853445 · HPX
Ciba Vision Care
Ophthalmic · 105d
Cleared Nov 29, 1985
PENOX HIGH FLOW MANIFOLD
K853775 · BYJ
Penox Technologies, Inc.
Anesthesiology · 80d
Cleared Nov 27, 1985
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
K850683 · DEB
Kent Laboratories, Inc.
Immunology · 279d