BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Passive Sphere

    Reg #: 3012075008 · FEI: 3012075008 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synaptive Medical Inc
    Registration Number
    3012075008
    FEI Number
    3012075008
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5055 Satellite Drive, Unit #1
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K033621

    Owner / Operator

    Firm Name
    Synaptive Medical Inc
    Operator Number
    10046804
    Address
    5055 Satellite Drive, Unit #1
    City
    Mississauga
    State
    Ontario
    Postal Code
    L4W 5K7
    Country
    CA
    Correspondent
    Michael McDonald

    US Agent

    Business Name
    Paladin Medical, Inc.
    Contact Name
    Elaine Duncan
    Address
    415 Valley View Trl
    City
    Houlton
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    Passive Sphere

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device