BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TORAX MEDICAL, INC.

    Reg #: 3008766073 · FEI: 3008766073 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    TORAX MEDICAL, INC.
    Registration Number
    3008766073
    FEI Number
    3008766073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4545 Creek Road
    City
    Cincinnati
    State
    OH
    ZIP
    45242
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201035
    PMA Number
    H130006

    Owner / Operator

    Firm Name
    Torax Medical Inc.
    Operator Number
    10040266
    Address
    4545 Creek Road
    City
    Cincinnati
    State
    OH
    Postal Code
    45242
    Country
    US
    Correspondent
    Kim Shoemaker

    Products

    Device Name Product Code
    Implanted Fecal Incontinence Device MIP
    Mechanical Compression Device Fecal Incontinence (Non-Manually Operated) PMH
    Implant, Anti-Gastroesophageal Reflux LEI
    Laparoscopic Accessories, Esophageal Sizing QJN

    Proprietary Names

    FENIX Continence Restoration System LINX Reflux Management System ETHICON Linx Esophagus Sizing Tool ETHICON LINX® Esophagus Sizing Tool

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility