BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OXOS MEDICAL, INC

    Reg #: 3018077344 · FEI: 3018077344 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    OXOS MEDICAL, INC
    Registration Number
    3018077344
    FEI Number
    3018077344
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1100 Peachtree St Ne Ste 700
    City
    Atlanta
    State
    GA
    ZIP
    30309
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212654

    Owner / Operator

    Firm Name
    OXOS Medical, Inc
    Operator Number
    10080806
    Address
    1100 Peachtree Street NE, Suite 700
    City
    Atlanta
    State
    GA
    Postal Code
    30309
    Country
    US

    Products

    Device Name Product Code
    Tube Mount, X-Ray, Diagnostic IYB
    System, X-Ray, Mobile IZL
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    Emitter Tripod, ACSY-S015 Point of Care Cart, ACSY-S012 Weight Bearing Foot and Ankle System, ACSY-S016 Point of Care Cart Cassette Holder, ACSY-S014 OXBox Integrated Travel Case, ACSY-S021 Micro C Medical Imaging System, M01 Micro C Foot Pedal, ACSY-P036 Load Bearing Cassette Plate, ACSY-S009 MC2 Portable X-ray System Cart Wireless Foot Pedal MC2 Portable X-Ray System Foot and Ankle Stand

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device