BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FZIOMED, INC.

    Reg #: 2031637 · FEI: 3004474407 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    FZIOMED, INC.
    Registration Number
    2031637
    FEI Number
    3004474407
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    231 BONETTI DR
    City
    San Luis Obispo
    State
    CA
    ZIP
    93401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K253326

    Owner / Operator

    Firm Name
    FZIOMED, INC.
    Operator Number
    9034681
    Address
    231 BONETTI DR., --
    City
    San Luis Obispo
    State
    CA
    Postal Code
    93401
    Country
    US
    Correspondent
    Lisa S Gawehn

    Products

    Device Name Product Code
    Inhibitor, Postoperative Fibrosis (Adhesion Barrier) OZJ
    Barrier, Absorbable, Adhesion MCN
    Absorbable Gel For Intraoperative Use In Spine Surgery QVL
    Inhibitor, Peridural Fibrosis (Adhesion Barrier) MLQ

    Proprietary Names

    DYNAVISC Oxiplex/AP Oxiplex/IU Intercoat AP Intercoat IU Oxiplex Oxiplex 1mL MediShield Interpose Oxiplex/SP Gel MediShield 1mL

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198