Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
76729–76752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · HWC
Arthrex, Inc.
Orthopedic · 85d
Cleared Apr 02, 2002
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL...
K020221 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 70d
Cleared Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 01, 2002
RE-USABLE STERILIZATION POUCH / BAG
K013715 · FRG
Quality Products of Montana
General Hospital · 144d
Cleared Apr 01, 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
K020629 · FPA
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 29, 2002
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F,...
K013779 · FLL
Mesure Technology
General Hospital · 136d
Cleared Mar 29, 2002
LIFEGUARD SAFETY INFUSION SET
K013871 · FPA
Horizon Medical Products, Inc.
General Hospital · 128d
Cleared Mar 29, 2002
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K014302 · MNH
Pisharodi Surgicals, Inc.
Orthopedic · 88d
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