BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MENDAERA, INC.

    Reg #: 3031851875 · FEI: 3031851875 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MENDAERA, INC.
    Registration Number
    3031851875
    FEI Number
    3031851875
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    700 S Claremont St Ste 200
    City
    San Mateo
    State
    CA
    ZIP
    94402
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250524

    Owner / Operator

    Firm Name
    Mendaera, Inc.
    Operator Number
    10093797
    Address
    700 S. Claremont St., Suite 200
    City
    San Mateo
    State
    CA
    Postal Code
    94402
    Country
    US
    Correspondent
    Danielle McDonnell

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Robot cover 5-pack (Arm only drape) Focalist Robot Drape, 5 pack Focalist Robot Drape Probe + Robot Drape Kit Universal Instrument Guide Kit - Long Mendaera Universal Instrument Interface, Long Focalist Robot and Probe Drape LONG BOX KIT BOX KIT, INSTRUMENT INTERFACE, SHORT, FOCALIST BOX KIT, RAIL, LONG BOX KIT, DRAPE, FULL, FOCALIST BOX KIT, INSTRUMENT INTERFACE, LONG, FOCALIST Focalist Universal Instrument Guide Kit, Short BOX KIT, RAIL, SHORT Focalist Universal Instrument Guide Kit, Long, 5 pack Robot Drape Kit FULL BOX KIT Probe + robot cover 5-pack (full drape) SHORT BOX KIT BOX KIT, DRAPE, FULL ROBOT DRAPE BOX KIT BOX KIT, DRAPE, ARM PROBE AND ROBOT DRAPE BOX KIT ROBOT AND PROBE DRAPE BOX KIT SHORT RAIL BOX KIT Mendaera Guidance System Long instrument guide 5-pack FULL DRAPE BOX KIT Focalist Universal Instrument Guide Kit, Long BOX KIT, DRAPE, ARM, FOCALIST ARM BOX KIT Universal Instrument Guide Kit - Short LONG RAIL BOX KIT Mendaera Universal Instrument Interface, Short Focalist Probe and Robot Drape Focalist Universal Instrument Guide Kit, Short, 5 pack ARM DRAPE BOX KIT Focalist Probe and Robot Drape, 5 pack Short instrument guide 5-pack

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device