BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fusion

    Reg #: 3009970070 · FEI: 3009970070 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MONTERIS MEDICAL CORP
    Registration Number
    3009970070
    FEI Number
    3009970070
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    131 Cheshire Lane, Suite 100
    City
    Minnetonka
    State
    MN
    ZIP
    55305
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222983

    Owner / Operator

    Firm Name
    Monteris Medical Corp
    Operator Number
    10042500
    Address
    131 Cheshire Lane Suite 100
    City
    Minnetonka
    State
    MN
    Postal Code
    55305
    Country
    US

    Products

    Device Name Product Code
    Neurosurgical Laser With Mr Thermography ONO
    Powered Laser Surgical Instrument GEX
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    Fusion M-Vision NeuroBlate Fusion-S

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device