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
74113–74136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2002
OSSTAPLE
K023203 · JDR
Biomedical Ent., Inc.
Orthopedic · 22d
Cleared Oct 17, 2002
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · JWH
Zimmer, Inc.
Orthopedic · 21d
Cleared Oct 17, 2002
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER...
K023250 · JJY
Cliniqa Corporation
Chemistry · 17d
Cleared Oct 17, 2002
SAS STREPALERT
K023270 · GTY
Sa Scientific, Inc.
Microbiology · 16d
Cleared Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 16, 2002
SANARUS INDICA MARKER SYSTEM
K020054 · FZP
Sanarus Medical, Inc.
General & Plastic Surgery · 281d
Cleared Oct 16, 2002
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
K021889 · KKY
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 131d
Cleared Oct 16, 2002
MOIST PUNCTAL PLUG SYSTEM
K021936 · LZU
Moist Medical, Inc.
Ophthalmic · 126d
Cleared Oct 16, 2002
NOVUS SPECTRA
K022327 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Oct 16, 2002
OPTICAL INTEGRITY GENERAL SHAPED FIBER
K022338 · GEX
Optical Integrity, Inc.
General & Plastic Surgery · 90d
Cleared Oct 16, 2002
DIODENT DENTAL LASER SYSTEM
K022351 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 89d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE,...
K022357 · DQX
Boston Scientific, Target
Cardiovascular · 89d
Cleared Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
K022637 · HMY
Becton, Dickinson & CO
Ophthalmic · 69d
Cleared Oct 16, 2002
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K022754 · DXC
S & T AG
Cardiovascular · 58d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · MKW
Dade Behring, Inc.
Chemistry · 30d
Cleared Oct 16, 2002
OLEEVA FABRIC
K023136 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 26d
Cleared Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 8d
Cleared Oct 15, 2002
POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
K022016 · LYY
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 117d
Cleared Oct 15, 2002
SANARUS VISICA TREATMENT SYSTEM
K022314 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Oct 15, 2002
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE...
K022566 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 74d
Cleared Oct 15, 2002
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
K022668 · GKZ
Bayer Diagnostics Corp.
Hematology · 64d
Cleared Oct 11, 2002
REPROCESSED IMAGING CATHETERS
K012537 · OWQ
Sterilmed, Inc.
Cardiovascular · 430d
Cleared Oct 11, 2002
KOWA AUTOMATED TONOMETER KT-500
K013805 · HKX
Kowa Optimed, Inc.
Ophthalmic · 330d
Cleared Oct 11, 2002
QUANTUM, MODELS SR, HR, DL
K020839 · GEX
Lumenis, Inc.
General & Plastic Surgery · 210d