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
38137–38160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2014
MOTEX POWDERED NITRILE SURGICAL GLOVES
K132802 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 21, 2014
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
K132937 · EBG
Harvest Dental Products, LLC
Dental · 245d
Cleared May 21, 2014
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
K133428 · BZG
Medikro OY
Anesthesiology · 194d
Cleared May 21, 2014
SILC FIXATION SYSTEM
K133482 · OWI
Globus Medical, Inc.
Orthopedic · 189d
Cleared May 21, 2014
CARDIOHELP SYSTEM
K133598 · DTQ
Maquet Cardiopulmonary, AG
Cardiovascular · 180d
Cleared May 21, 2014
NOVOFINE PLUS 32G 4 MM
K133738 · FMI
Novo Nordisk, Inc.
General Hospital · 163d
Cleared May 21, 2014
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
K134043 · FLL
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 141d
Cleared May 21, 2014
HYGEDENT ALGINATE IMPRESSION MATERIAL
K140074 · ELW
Hygedent, Inc.
Dental · 128d
Cleared May 21, 2014
SPRINGTMS TOTAL MIGRAINE SYSTEM
K140094 · OKP
Eneura Therapeutics, LLC
Neurology · 127d
Cleared CT May 21, 2014
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
K140151 · QEY
Btg International, Inc.
Cardiovascular · 119d
Cleared May 21, 2014
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
K140169 · LJT
Cook Incorporated
General Hospital · 118d
Cleared May 21, 2014
SKINTACT
K140340 · GXY
Leonhard Lang GmbH
Neurology · 99d
Cleared May 21, 2014
GALAFLEX MESH
K140533 · OOD
Tepha, Inc.
General & Plastic Surgery · 78d
Cleared May 21, 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · KWQ
Zimmer Spine, Inc.
Orthopedic · 72d
Cleared May 20, 2014
NAMSA CHEMICAL PROCESS
K132291 · JOJ
North American Science Assoc., Inc.
General Hospital · 301d
Cleared May 20, 2014
OSTEOSPAN MORPHEUS
K132377 · MQV
Biogennix, LLC
Orthopedic · 293d
Cleared May 20, 2014
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K133082 · GXN
Osteosymbionics, LLC
Neurology · 232d
Cleared May 20, 2014
PRIME ZOOM STRETCHER
K140095 · INK
Stryker Corporation
Physical Medicine · 126d
Cleared May 20, 2014
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL...
K140165 · DWF
Medtronic, Inc.
Cardiovascular · 118d
Cleared May 20, 2014
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446 · MKZ
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 20, 2014
BD VIPER LT SYSTEM
K140447 · OOI
Becton, Dickinson and Company
Microbiology · 88d
Cleared May 20, 2014
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · LSL
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 20, 2014
ASAP OTC WOUND DRESSING GEL
K140483 · FRO
Abl Medical, LLC
General & Plastic Surgery · 83d
Cleared May 20, 2014
Y WIRE 2
K140576 · HXI
Safewire, LLC
Orthopedic · 75d