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
60769–60792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2006
ENTEROCOCCUS FAECALIS PNA FISH
K063127 · OAH
Advandx, Inc.
Microbiology · 70d
Cleared Dec 22, 2006
ALLERGEAZE PATCH TEST CHAMBERS
K063160 · KXF
Smartpractice
General Hospital · 66d
Cleared Dec 22, 2006
I.T.S. PELVIC RECONSTRUCTION SYSTEM
K063166 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 65d
Cleared Dec 22, 2006
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
K063224 · NZB
Gentris Corporation
Chemistry · 59d
Cleared Dec 22, 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 44d
Cleared Dec 22, 2006
O&P BIVALVE CRANIAL MOLDING HELMET
K063395 · MVA
Orthotic & Prosthetic Lab, Inc.
Neurology · 43d
Cleared Dec 22, 2006
ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
K063474 · ITI
Imc-Heart Way LLC
Physical Medicine · 36d
Cleared Dec 22, 2006
PATIENT DATA HANDLER & DEVICES (PDH&D)
K063484 · DRG
Intermed Advisors, Inc.
Cardiovascular · 35d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS...
K063543 · CIG
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Dec 22, 2006
AEQUALIS HUMERAL PLATE
K063551 · KTT
Tornier
Orthopedic · 28d
Cleared Dec 21, 2006
UNISYN HA PLASMA MODULAR HIP
K062383 · LWJ
Hayes Medical, Inc.
Orthopedic · 128d
Cleared Dec 21, 2006
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · KGO
Hartalega Sdn Bhd
General Hospital · 83d
Cleared Dec 21, 2006
VS-800 VITAL SIGNS MONITOR
K063055 · MWI
Shenzhen Mindray Bio-Medical...
Cardiovascular · 77d
Cleared Dec 21, 2006
ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX
K063182 · DYB
Enpath Medical, Inc.
Cardiovascular · 63d
Cleared Dec 21, 2006
INTEGRA RADIONICS IMAGEFUSION 3
K063230 · MUJ
Integra Radionics, Inc.
Radiology · 57d
Cleared Dec 21, 2006
FILM DIGITZER, MODEL 2908 MAMMO PRO
K063424 · LMA
Array Corp.
Radiology · 38d
Cleared Dec 21, 2006
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K063492 · LON
bioMerieux, Inc.
Microbiology · 34d
Cleared Dec 21, 2006
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
K063493 · IYN
Boston Scientific Corp
Radiology · 31d
Cleared Dec 21, 2006
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
K063518 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 30d
Cleared Dec 21, 2006
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
K063547 · MWI
Witt Biomedical Corp
Cardiovascular · 27d
Cleared Dec 21, 2006
AUTOPULSE RESUSCITATION SYSTEM MODEL100
K063602 · DRM
Zoll Circulation
Cardiovascular · 17d
Cleared Dec 21, 2006
CITRIC ACID 20% SOLUTION, MODEL 329
K063703 · KJJ
Ultradent Products, Inc.
Dental · 8d
Cleared Dec 20, 2006
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K061227 · FRO
The Hymed Group Corp.
General & Plastic Surgery · 232d
Cleared Dec 20, 2006
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
K061461 · LPH
Zimmer, Inc.
Orthopedic · 208d