BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KLARITY MEDICAL PRODUCTS, LLC

    Reg #: 1530561 · FEI: 3001236129 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    16
    Establishment Types
    5
    Classifications
    5

    Registration Details

    Registration Name
    KLARITY MEDICAL PRODUCTS, LLC
    Registration Number
    1530561
    FEI Number
    3001236129
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    600 Industrial Pkwy
    City
    Heath
    State
    OH
    ZIP
    43056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K781151

    Owner / Operator

    Firm Name
    KLARITY MEDICAL PRODUCTS, LLC
    Operator Number
    9031393
    Address
    600 Industrial Pkwy, --
    City
    Heath
    State
    OH
    Postal Code
    43056
    Country
    US
    Correspondent
    Michelle P Fritch

    Products

    Device Name Product Code
    Splint, Hand, And Components ILH
    Material, Impression ELW
    Accelerator, Linear, Medical IYE
    Holder, Head, Radiographic IWY
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    Klarity White, Contour Blend, Contour Pro, Klarity Easy Fit, Klarity Solo Klarity Bolus TrueForm Cushion Klarity AccuCushion Klarity Vacuum Bag Klarity Moldable Cushion AccuCushion Klarity Prone Head Support, Klarity Carbon Fiber Head Support, and Klarity Lateral Head Support MEDIBORD Leg Positioner SBRT System KLARITY BASEPLATES OPTEK BASEPLATES Klarity Thermoplastic, Klarity Green, Klarity White, Klarity Blue, BiteLok Klarity Promise Baseplate Klarity SRS Baseplate

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198