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
60889–60912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2006
ACCULOC BREAST LOCALIZATION SYSTEM
K063274 · IYE
Northwest Medical Physics Equipment,...
Radiology · 43d
Cleared Dec 12, 2006
OPAL-RAD
K063337 · LLZ
Viztek, Inc.
Radiology · 36d
Cleared Dec 12, 2006
IMCO-STAT
K063392 · LLZ
Imco Technologies
Radiology · 33d
Cleared Dec 12, 2006
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34,...
K063414 · KWA
Encore Medical, L.P.
Orthopedic · 29d
Cleared Dec 12, 2006
VISUALASE ENVISION SOFTWARE SYSTEM
K063505 · LLZ
Biotex, Inc.
Radiology · 22d
Cleared Dec 12, 2006
ECHELON MR-RCC-150 CARDIAC COIL
K063513 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 21d
Cleared Dec 12, 2006
PEAK BOND, MODEL 5133
K063557 · KLE
Ultradent Products, Inc.
Dental · 15d
Cleared Dec 12, 2006
VASCUTRAK PTA DILATION CATHETER
K063657 · PNO
Ymed, Inc.
Cardiovascular · 4d
Cleared Dec 11, 2006
M-BOLUS EMBOLIC MICROSPHERES
K052509 · HCG
Scion Cardio-Vascular, Inc.
Neurology · 454d
Cleared Dec 11, 2006
MODULAR HYBRID GLENOID
K060694 · KWS
Biomet Manufacturing Corp
Orthopedic · 271d
Cleared Dec 11, 2006
PROCEED VENTRAL PATCH
K061533 · FTL
Ethicon, Inc.
General & Plastic Surgery · 192d
Cleared Dec 11, 2006
MINISPIR
K061875 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 161d
Cleared Dec 11, 2006
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
K062280 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 126d
Cleared Dec 11, 2006
BAND-AID(R) BRAND LIQUID BANDAGE
K062602 · KMF
Johnson & Johnson Consumer Companies,...
General & Plastic Surgery · 101d
Cleared Dec 11, 2006
ORI F6T DRY ECG MONITORING ELECTRODE
K062760 · DRX
Orbital Research, Inc.
Cardiovascular · 87d
Cleared Dec 11, 2006
USI DENTAL SCALER, 25XXX SERIES
K062791 · ELC
Ultrasonic Services, Inc.
Dental · 84d
Cleared Dec 11, 2006
MUGARD MUCOADHESIVE ORAL WOUND RINSE
K062795 · OLR
Access Pharmaceuticals, Inc.
General & Plastic Surgery · 84d
Cleared Dec 11, 2006
MODIFICATION TO MODEL 750 SERIES MONITOR
K063087 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 62d
Cleared Dec 11, 2006
ISECURE SYRINGE CARTRIDGE HOLDER
K063180 · IQG
Hospira, Inc.
General Hospital · 53d
Cleared Dec 11, 2006
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528,...
K063239 · FPK
Hospira, Inc.
General Hospital · 46d
Cleared Dec 11, 2006
AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS...
K063379 · DKZ
Amedica Biotech, Inc.
Toxicology · 33d
Cleared Dec 11, 2006
WICK ELECTRODE, MODEL M019260
K063402 · GXY
Intelligent Hearing Systems
Neurology · 32d
Cleared Dec 11, 2006
XIA STAINLESS STEEL SPINAL SYSTEM
K063428 · NKB
Stryker Spine
Orthopedic · 28d
Cleared Dec 08, 2006
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
K061902 · DWJ
Inditherm Medical
Cardiovascular · 156d