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
76129–76152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305 · HTY
Arthrotek, Inc.
Orthopedic · 88d
Cleared Mar 29, 2002
DYNA INTRA-LIMBAL LENS
K020006 · HQD
Lens Dynamics, Inc.
Ophthalmic · 86d
Cleared Mar 29, 2002
OPTILUX CURING LIGHTS
K020267 · EBZ
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Mar 29, 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · CFE
Helena Laboratories
Chemistry · 45d
Cleared Mar 29, 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Mar 29, 2002
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K020659 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 29, 2002
GAMMA 3 LAG SCREW
K020677 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Mar 29, 2002
O'REGAN DISPOSABLE ANOSCOPE
K020702 · FER
Canadian Theatre Products , Ltd.
Gastroenterology & Urology · 25d
Cleared Mar 29, 2002
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
K020871 · LON
bioMerieux, Inc.
Microbiology · 91d
Cleared Mar 29, 2002
D.SIGN 15 (DW286 B)
K020898 · EJH
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Mar 29, 2002
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
K020973 · GEX
Surgilight, Inc.
General & Plastic Surgery · 3d
Cleared Mar 28, 2002
SURETONE
K011588 · IPF
Suretone International
Physical Medicine · 309d
Cleared Mar 28, 2002
THE HAMMER MODEL H100
K012041 · DXC
Tenacore Holdings, Inc.
Cardiovascular · 272d
Cleared Mar 28, 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
K013551 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 155d
Cleared Mar 28, 2002
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
K013714 · FPA
Codan US Corp.
General Hospital · 140d
Cleared Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
K013984 · MOI
Diagnostic Products Corp.
Immunology · 115d
Cleared Mar 28, 2002
ORTHOSS RESORBABLE BONE VOID FILLER
K014289 · LYC
Geistlich-Pharma
Dental · 90d
Cleared Mar 28, 2002
ENTEC PLASMA WANDS
K014290 · GEI
Arthrocare Corp.
General & Plastic Surgery · 90d
Cleared Mar 28, 2002
UNIFIL FLOW
K020342 · EBF
GC America, Inc.
Dental · 55d
Cleared Mar 28, 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · DIO
Dade Behring, Inc.
Toxicology · 45d
Cleared Mar 28, 2002
PBS, PBSW WITH CATIONS AND PHENOL RED
K020490 · MQL
Conception Technologies
Obstetrics & Gynecology · 43d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER
K020621 · GEY
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K020622 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Mar 28, 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 27d