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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87913–87936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1998
QUADRANT UNICHEM
K983751 · EBF
Cavex Holland BV
Dental · 38d
Cleared Nov 30, 1998
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K983869 · LRJ
Caltech Industries, Inc.
General Hospital · 28d
Cleared Nov 30, 1998
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K983975 · FRN
Belmont Instrument Corp.
General Hospital · 21d
Cleared Nov 30, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN...
K984034 · MOB
Zeus Scientific, Inc.
Immunology · 18d
Cleared Nov 27, 1998
FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
K983066 · ITI
Teftec Corp.
Physical Medicine · 86d
Cleared Nov 27, 1998
SUTURE WELDING SYSTEM AND KIT (SWK)
K983108 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 84d
Cleared Nov 27, 1998
DOMINATOR
K983681 · IOR
Impact Wheelchair Manufacture, Inc.
Physical Medicine · 38d
Cleared Nov 25, 1998
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
K981365 · MSD
Sherwood Medical Co.
Gastroenterology & Urology · 224d
Cleared Nov 25, 1998
AB FLU OIA
K981651 · PSZ
Biostar, Inc.
Microbiology · 198d
Cleared Nov 25, 1998
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
K981802 · MKJ
Bio-Detek, Inc.
Cardiovascular · 188d
Cleared Nov 25, 1998
ACUTRON MENTOR MODEL 961
K981976 · GZJ
Microcurrent Research, Inc.
Neurology · 177d
Cleared Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027 · LFZ
DiaSorin, Inc.
Microbiology · 176d
Cleared Nov 25, 1998
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · MLD
Medical Data Electronics
Cardiovascular · 163d
Cleared Nov 25, 1998
CRYOPRO MAXI AND CRYOPRO MINI
K982280 · GEH
Cortex Technology Aps
General & Plastic Surgery · 148d
Cleared Nov 25, 1998
SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM
K982322 · KWP
Synthes (Usa)
Orthopedic · 146d
Cleared Nov 25, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
EA-D IGM ELISA TEST SYSTEM
K982350 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
VCA IGM ELISA TEST SYSTEM
K982352 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
PLUS BIPOLAR PROSTHESIS COCRMO
K982447 · KWY
Plus Orthopedics
Orthopedic · 133d
Cleared Nov 25, 1998
PREMIER GIARDIA
K982711 · MHI
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Nov 25, 1998
CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI
K983004 · JWH
Hayes Medical, Inc.
Orthopedic · 89d
Cleared Nov 25, 1998
PERIPHERAL AVE STENT SYSTEM
K983008 · FGE
Peripheral Ave
Gastroenterology & Urology · 89d
Cleared Nov 25, 1998
BSM- BONE SUBSTITUTE MATERIAL
K983009 · GXP
Etex Corp.
Neurology · 89d
Cleared Nov 25, 1998
COMPACT KTP LASER
K983020 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 86d