BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Navi e

    Reg #: 3015499445 · FEI: 3015499445 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TRANSCEND BIOLOGICS, LLC
    Registration Number
    3015499445
    FEI Number
    3015499445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5916 Stone Creek Drive, Suite 120
    City
    The Colony
    State
    TX
    ZIP
    75056
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180461

    Owner / Operator

    Firm Name
    Transcend Biologics, LLC
    Operator Number
    10085985
    Address
    5916 Stone Creek Drive, Suite 120
    City
    The Colony
    State
    TX
    Postal Code
    75056
    Country
    US
    Correspondent
    Paul OBrien

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Navi e Navi s Piloter Exp Navi X Piloter P Piloter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198