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
45361–45384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2012
ZIMMER CONTOUR PROVISIONAL COPING
K113092 · NHA
Zimmer Dental, Inc.
Dental · 96d
Cleared Jan 23, 2012
PCXX VARNISH
K113146 · LBH
Ross Healthcare, Inc.
Dental · 91d
Cleared Jan 23, 2012
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
K113301 · EFB
Dentalez, Inc.
Dental · 76d
Cleared Jan 23, 2012
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI...
K113661 · LAF
Lin-Zhi International, Inc.
Chemistry · 41d
Cleared Jan 20, 2012
TORQTECH
K103697 · EGS
J. Morita USA, Inc.
Dental · 396d
Cleared Jan 20, 2012
CELLTRACKS AUTOPREP SYSTEM
K110406 · NQI
Veridex, LLC
Pathology · 340d
Cleared Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874 · JZG
Siemens Healthcare Diagnostics, Inc.
Immunology · 297d
Cleared Jan 20, 2012
RELIANCE SPINAL SCREW SYSTEM
K110896 · MNI
Reliance Medical Systems, LLC
Orthopedic · 296d
Cleared Jan 20, 2012
SURGICAL TISSUE MANAGEMENT SYSTEM
K111202 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 266d
Cleared Jan 20, 2012
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC...
K112161 · KHO
Radiometer Medical Aps
Chemistry · 177d
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · LIP
Siemens Healthcare Diagnostics, Inc.
Microbiology · 158d
Cleared Jan 20, 2012
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · DXC
Medtronic Xomed, Inc.
Cardiovascular · 129d
Cleared Jan 20, 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725 · MRG
DiaSorin, Inc.
Chemistry · 122d
Cleared Jan 20, 2012
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
K112918 · FRG
Cardinal Health200, LLC
General Hospital · 109d
Cleared Jan 20, 2012
NEUROTECH RECOVERY
K112934 · GXY
Bio-Medical Research, Ltd.
Neurology · 109d
Cleared Jan 20, 2012
SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
K112936 · MEG
Rexam Consummer Plastics Inc.D/B/A...
General Hospital · 109d
Cleared Jan 20, 2012
DISPOSABLE HEMOSTATIC Y-CONNECTORS
K113132 · DTL
Coeur, Inc.
Cardiovascular · 88d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · MBI
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Jan 20, 2012
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
K113302 · FRC
North American Science Assoc., Inc.
General Hospital · 73d
Cleared Jan 20, 2012
SPECTRA OPTIA APHERESIS SYSTEM
K113480 · LKN
Caridianbct, Inc..
Gastroenterology & Urology · 58d
Cleared Jan 20, 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 53d
Cleared Jan 20, 2012
OPTICAGE INTERBODY FUSION DEVICE
K113527 · MAX
Interventional Spine, Inc.
Orthopedic · 51d
Cleared Jan 20, 2012
REGENEROSS ALLOGRAFT PLUS MINERLIZED
K113645 · NUN
Biomet Interpore Cross
Dental · 39d
Cleared Jan 20, 2012
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
K113709 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 32d