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
142993–143016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1986
COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
K862667 · EJH
Austenal Dental, Inc.
Dental · 17d
Cleared Jul 31, 1986
RIONET HEARING AID HB-35PT
K862670 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 31, 1986
FLUOR-ETCH GEL ETCHANT
K862695 · EBC
Teledyne, Inc.
Dental · 16d
Cleared Jul 31, 1986
EUGENOL USP
K862745 · EMB
E&D Dental Manufacturing Co.
Dental · 10d
Cleared Jul 31, 1986
HEARING AID, UNITRON MODEL UF11
K862760 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Jul 30, 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · DSK
Spacelabs, Inc.
Cardiovascular · 155d
Cleared Jul 30, 1986
PS SYSTEM WITH SD-200 DOPPLER
K861358 · ITX
Johnson & Johnson Professionals, Inc.
Radiology · 111d
Cleared Jul 30, 1986
ACUSON L558 TRANSDUCER
K861579 · JOP
Acuson Computed Sonography
Cardiovascular · 93d
Cleared Jul 30, 1986
ACUSON S519 TRANSDUCER
K861596 · JOP
Acuson Computed Sonography
Cardiovascular · 92d
Cleared Jul 30, 1986
LAURIER SANTARY NAPKIN (MODIFICATION)
K862269 · HHD
Kao Corp.
Obstetrics & Gynecology · 47d
Cleared Jul 30, 1986
POLYESTER SPONGE PATTIE
K862494 · HBA
American Silk Sutures, Inc.
Neurology · 29d
Cleared Jul 30, 1986
TREACE MEDICAL MICRO INSTRUMENT WIPE
K862582
Treace Medical, Inc.
General & Plastic Surgery · 23d
Cleared Jul 30, 1986
PACEMAKER LEAD ADAPTER
K862656 · DTD
Cordis Corp.
Cardiovascular · 16d
Cleared Jul 30, 1986
TRACHEOSTOMY CARE TRAY
K862663 · LRQ
Welmed Systems, Inc.
General & Plastic Surgery · 16d
Cleared Jul 30, 1986
JEDMED CCD CAMERA SYSTEM
K862664 · FWD
Jedmed Instrument Co.
General & Plastic Surgery · 16d
Cleared Jul 30, 1986
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
K862696 · HBT
Downs Surgical , Ltd.
General & Plastic Surgery · 15d
Cleared Jul 30, 1986
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702 · LPH
Depuy, Inc.
Orthopedic · 15d
Cleared Jul 30, 1986
HAND MIRROR (ENDOSCOPE)
K862717 · GCO
Simpson/Basye, Inc.
Gastroenterology & Urology · 13d
Cleared Jul 29, 1986
RIGHT-DAY URINARY LH (EIA)
K860538 · CEP
Leeco Diagnostics, Inc.
Chemistry · 167d
Cleared Jul 29, 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766 · DPW
Millar Instruments, Inc.
Cardiovascular · 148d
Cleared Jul 29, 1986
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
K861703 · JHJ
Leeco Diagnostics, Inc.
Chemistry · 85d
Cleared Jul 29, 1986
DU PONT DRUG CALIBRATOR
K861786 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 82d
Cleared Jul 29, 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792 · CKA
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Jul 29, 1986
OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
K862061 · LYC
Coors Biomedical Co.
Dental · 60d