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
45793–45816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2011
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
K110786 · NSU
GenMark Diagnostics, Inc.
Chemistry · 255d
Cleared Dec 02, 2011
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED...
K111751 · HIN
Ethicon, Inc.
Obstetrics & Gynecology · 163d
Cleared Dec 02, 2011
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
K111907 · EIA
Shanghai Dynamic Industry Co., Ltd.
Dental · 150d
Cleared Dec 02, 2011
MAGNESIUM ASSAY
K111915 · JGJ
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 149d
Cleared Dec 02, 2011
VOCARE MYHEALTH TABLET
K111922 · DRG
Vocare, Inc.
Cardiovascular · 149d
Cleared Dec 02, 2011
VANTAGE TITAN HSR
K112003 · LNH
Toshibamedical Systems Corporation
Radiology · 142d
Cleared Dec 02, 2011
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
K112559 · DRG
Medapps, Inc.
Cardiovascular · 91d
Cleared Dec 02, 2011
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
K112779 · LPH
Omnlife Science
Orthopedic · 67d
Cleared Dec 02, 2011
MOBILE MIM
K112930 · LLZ
Mim Software, Inc.
Radiology · 60d
Cleared Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
K113143 · LLL
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Dec 02, 2011
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · DXS
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 02, 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · LPL
CooperVision, Inc.
Ophthalmic · 30d
Cleared Dec 02, 2011
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
K113267 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Dec 02, 2011
ANGIOJET ULTRA DVX THROMBECTOMY SET
K113428 · QEZ
Medrad, Inc.
Cardiovascular · 11d
Cleared Dec 01, 2011
ADVANCED TRAUMA DRESSING (ATD)
K101257 · QSY
Nanosys, Inc.
General & Plastic Surgery · 576d
Cleared Dec 01, 2011
PRESTIGE 24I
K103531 · CFR
Tokyo Boeki Medisys, Inc.
Chemistry · 365d
Cleared Dec 01, 2011
NEWPORT HT70 VENTILATOR
K111146 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 223d
Cleared Dec 01, 2011
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
K111248 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 212d
Cleared Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
K111335 · CKG
Tosoh Bioscience, Inc.
Chemistry · 203d
Cleared Dec 01, 2011
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
K111458 · KKX
Gri Medical & Electronic Technology...
General Hospital · 189d
Cleared Dec 01, 2011
GUIDELINER V2 CATHETER
K112082 · DQY
Vascular Solutions, Inc.
Cardiovascular · 133d
Cleared Dec 01, 2011
ACCULIF TL-PEEK IBF CAGE
K112095 · MAX
Coalign Innovations, Inc.
Orthopedic · 132d
Cleared Dec 01, 2011
GENUINE FIRST AID CPR MASK
K112126 · CBP
Genuine First Aid, LLC
Anesthesiology · 129d
Cleared Dec 01, 2011
ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
K112138 · NHA
Astra Tech, Inc.
Dental · 128d