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
70417–70440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971,...
K033818 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Jan 08, 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · MQP
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jan 08, 2004
PRECISION XCEED DIABETES MONITORING SYSTEM
K033845 · NBW
Abbott Laboratories
Chemistry · 28d
Cleared Jan 08, 2004
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987 · DTM
Dideco S.P.A.
Cardiovascular · 16d
Cleared Jan 08, 2004
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K034003 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jan 08, 2004
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
K034013 · LKJ
Corgenix, Inc.
Immunology · 15d
Cleared Jan 07, 2004
OSTEOMED ORTHODONTIC SCREW SYSTEM
K031936 · DZE
Osteomed LP
Dental · 198d
Cleared Jan 07, 2004
COMPREHENSIVE NEUROMUSCULAR PROFILER
K031995 · IKN
Medical Technologies Unlimited, Inc.
Neurology · 194d
Cleared Jan 07, 2004
PREMIER PLUS
K032003 · GZJ
American Imex
Neurology · 194d
Cleared Jan 07, 2004
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K032031 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 190d
Cleared Jan 07, 2004
SEA-BAND
K033268 · MVV
Sea-Band UK , Ltd.
Neurology · 90d
Cleared Jan 07, 2004
SPINEASSIST DEVICE
K033413 · HAW
Mazor Surgical Technologies , Ltd.
Neurology · 72d
Cleared Jan 07, 2004
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
K033449 · EJR
Professional Dental Technologies...
Dental · 70d
Cleared Jan 07, 2004
GENESIS VERTICAL PLATFORM LIFT
K033469 · ING
Garaventa Accessibility
Physical Medicine · 65d
Cleared Jan 07, 2004
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K033475 · OLV
Nihon Kohden America, Inc.
Neurology · 65d
Cleared Jan 07, 2004
LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
K033535 · PDU
Lumend, Inc.
Cardiovascular · 58d
Cleared Jan 07, 2004
VNUS VESSEL AND TISSUE COAGULATION SYSTEM
K033547 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 56d
Cleared Jan 07, 2004
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
K033660 · HBO
Rudolf Storz GmbH
Neurology · 47d
Cleared Jan 07, 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K033922 · DZE
Institut Straumann AG
Dental · 20d
Cleared Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
K033937 · JJY
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jan 06, 2004
CODA CX1 MOTION ANALYSIS SYSTEM
K033514 · LXJ
Charnwood Dynamics , Ltd.
Physical Medicine · 61d
Cleared Jan 06, 2004
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
K033659 · DKZ
Varian, Inc.
Toxicology · 46d
Cleared Jan 02, 2004
NOVA GLUCOSE CONTROL SOLUTIONS
K033433 · JJX
Nova Biomedical Corp.
Chemistry · 66d