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
58681–58704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2007
FLEXWARMER, MODELS KZ-1 AND KZ-2
K062644 · LGZ
Merlyn Associates, Inc.
General Hospital · 370d
Cleared Sep 11, 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 196d
Cleared Sep 11, 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · FLL
Microlife Intellectual Property GmbH
General Hospital · 194d
Cleared Sep 11, 2007
TRIBONE 80
K071121 · MQV
Biomatlante
Orthopedic · 144d
Cleared Sep 11, 2007
DELTA XTEND REVERSE SHOULDER MODULAR STEM
K071379 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 117d
Cleared Sep 11, 2007
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
K071465 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 105d
Cleared Sep 11, 2007
MODUS TRILOCK 2.0/2.3/2.5
K071612 · JEY
Medartis AG
Dental · 90d
Cleared Sep 11, 2007
FIDUCIAL MARKERS
K071614 · IYE
Civco
Radiology · 90d
Cleared Sep 11, 2007
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
K071700 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 82d
Cleared Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · JJY
Dade Behring, Inc.
Immunology · 55d
Cleared Sep 11, 2007
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
K072151 · NHA
Straumann USA
Dental · 39d
Cleared Sep 11, 2007
COR ANALYZER II, MODEL V1.7
K072242 · LLZ
Rcadia Medical Imaging , Ltd.
Radiology · 29d
Cleared Sep 10, 2007
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
K070694 · MVA
Mike Miner
Neurology · 181d
Cleared Sep 10, 2007
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT...
K071414 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 112d
Cleared Sep 10, 2007
TI2200 TRANSILLUMINATION CABLE
K071429 · NTK
Kerr Corporation
Dental · 110d
Cleared Sep 10, 2007
CORIN ADAPTOR SLEEVE
K071471 · KWL
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Sep 10, 2007
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K071486 · GZI
Restorative Therapies, Inc.
Neurology · 103d
Cleared Sep 10, 2007
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
K071507 · NBW
Polymer Technology Systems, Inc.
Chemistry · 101d
Cleared Sep 10, 2007
SBI TWISTOFIX
K071541 · HWC
Small Bone Innovations, Inc.
Orthopedic · 97d
Cleared Sep 10, 2007
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
K071565 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 95d
Cleared Sep 10, 2007
SANDMAN INTRO
K071575 · BZD
Mallinckrodt Developpement France
Anesthesiology · 94d
Cleared Sep 10, 2007
I-SURGE
K071965 · EFB
Satelec
Dental · 56d
Cleared Sep 10, 2007
QUICKIE QX MANUAL FOLDING WHEELCHAIR
K072153 · IOR
Sunrise Medical, Inc.
Physical Medicine · 38d
Cleared Sep 08, 2007
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
K072269 · QEZ
Possis Medical, Inc.
Cardiovascular · 24d