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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
53041–53064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2009
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
K091591 · BTR
Flexicare Medical, Ltd.
Anesthesiology · 15d
Cleared Jun 16, 2009
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150 · LCX
Turklab Medical Devices, Inc.
Chemistry · 419d
Cleared Jun 16, 2009
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
K081720 · ILY
Prime Herbs Corporation
Physical Medicine · 363d
Cleared Jun 16, 2009
STATIC VESSEL ANALYZER
K082196 · HKI
Imedos GmbH
Ophthalmic · 316d
Cleared Jun 16, 2009
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K082879 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
K082880 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
K082883 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 260d
Cleared Jun 16, 2009
ACTHYDERM
K083016 · EGJ
Microlab Americas, Inc.
Physical Medicine · 250d
Cleared Jun 16, 2009
ACUMED CLAVICLE SCREW SYSTEM
K083144 · JDW
Acumed, LLC
Orthopedic · 236d
Cleared Jun 16, 2009
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL...
K090721 · OCL
Medtronic
Cardiovascular · 90d
Cleared Jun 16, 2009
REJUVENATE MONOLITHIC SIZE 4 HIP STEM
K091161 · MEH
Howmedica Osteonics Corp.
Orthopedic · 56d
Cleared Jun 16, 2009
SUPRA 577.Y LASER
K091581 · HQF
Quantel Medical
Ophthalmic · 14d
Cleared Jun 15, 2009
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K081259 · MKJ
Defibtech, LLC
Cardiovascular · 409d
Cleared Jun 15, 2009
CLAVICLE PLATING SYSTEM
K090289 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 130d
Cleared Jun 15, 2009
HAMILTON-C2
K090468 · CBK
Hamilton Medical AG
Anesthesiology · 112d
Cleared Jun 15, 2009
ONCENTRA SIMULATION 2.3
K090706 · KPQ
Nucletron Corporation
Radiology · 90d
Cleared Jun 15, 2009
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
K091103 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared Jun 15, 2009
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K091484 · LYC
Novabone Products, LLC
Dental · 27d
Cleared Jun 15, 2009
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · MQB
Canon, Inc.
Radiology · 19d
Cleared Jun 12, 2009
INFANT SLEEP BEANIE
K082367 · FRP
Life Innovations, LLC
General Hospital · 298d
Cleared Jun 12, 2009
KLS MARTIN ELECTROSURGICAL INSTRUMENTS
K082505 · GEI
Kl Martin L.P.
General & Plastic Surgery · 287d
Cleared Jun 12, 2009
VEINWAVE, TC3000
K083352 · ONQ
Newlands Clinical Trials, Ltd.
General & Plastic Surgery · 211d
Cleared Jun 12, 2009
E-MATRIX GRAFT BONE EXTENDER
K083449 · MQV
Pioneer Surgical Technology
Orthopedic · 203d
Cleared Jun 12, 2009
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS
K083616 · GEX
Patholase, Inc.
General & Plastic Surgery · 186d