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
45913–45936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2011
CAROTID COIL
K112002 · MOS
Shanghai Chenguang Medical...
Radiology · 128d
Cleared Nov 18, 2011
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
K112050 · OBJ
Biosense Webster, Inc.
Cardiovascular · 123d
Cleared Nov 18, 2011
OBC BONE ANCHORED HEARING SYSTEM
K112053 · MAH
Oticon Medical AB
Ear, Nose, Throat · 122d
Cleared Nov 18, 2011
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K112132 · MQB
Medicatech USA
Radiology · 115d
Cleared Nov 18, 2011
TAPAS CATHETER
K112219 · MJN
Thermopeutix, Inc.
Cardiovascular · 108d
Cleared Nov 18, 2011
ONCENTRA PROSTATE 4.0
K112420 · JAQ
Nucletron
Radiology · 87d
Cleared Nov 18, 2011
VITREA CT MYOCARDIAL ANALYSIS
K112531 · LLZ
Vital Images, Inc.
Radiology · 79d
Cleared Nov 18, 2011
TRANSRADIAL ARTERY ACCESS DEVICES
K112554 · DYB
Teleflexmedical, Inc.
Cardiovascular · 77d
Cleared Nov 18, 2011
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
K112768 · LHN
Calypso Medical Technologies, Inc.
Radiology · 57d
Cleared Nov 18, 2011
SYNGO VIA MI WORKFLOWS
K113029 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 17, 2011
ACCELEDENT
K110661 · OYH
Orthoaccel Technologies, Inc.
Dental · 254d
Cleared Nov 17, 2011
HY-BOND RESIGLASS
K111855 · EMA
Shofu Dental Corp.
Dental · 141d
Cleared Nov 17, 2011
CLEARFIL DC CORE PLUS
K111982 · EBF
Kuraray America, Inc.
Dental · 128d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085 · HRS
Synthes USA Products, LLC
Orthopedic · 119d
Cleared Nov 17, 2011
DREAMBOND
K112118 · KLE
Bisco, Inc.
Dental · 115d
Cleared Nov 17, 2011
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
K112197 · HTY
Memometal Technologies
Orthopedic · 108d
Cleared Nov 17, 2011
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
K112214 · GZB
St. Jude Medical Neuromodulation
Neurology · 107d
Cleared Nov 17, 2011
CLEARWAY RX NB CATHETER
K113112 · DQY
Atrium Medical Corp.
Cardiovascular · 28d
Cleared Nov 17, 2011
INTELLIVUE MX40 PATIENT MONITOR
K113125 · DSI
Philips Medical Systems
Cardiovascular · 24d
Cleared Nov 17, 2011
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K113191 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 17d
Cleared Nov 17, 2011
MOBCARDIO SYSTEM
K113234 · DPS
Mobhealth Incorporation
Cardiovascular · 15d
Cleared Nov 16, 2011
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
K103818 · MXZ
Ventana Medical Sytems, Inc.
Pathology · 322d
Cleared Nov 16, 2011
HEALTHTRACKER
K110770 · DXN
Wistron Corporation
Cardiovascular · 243d
Cleared Nov 16, 2011
APOLLO
K111026 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 217d