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    Medtech SAS

    Manufacturer
    🇫🇷 France

    MEDTECH SAS

    FDA registration
    MEDTECH SAS·5 products·🇫🇷 France

    AD SWISS MEDTECH SA

    Manufacturer
    🇨🇭 Switzerland

    ROSA SURGICAL DEVICE

    FDA Adverse Event
    Malfunction ·MEDTECH SA·Product code HAW·September 17, 2018

    ATTUNE FB TIBIAL IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWA·May 14, 2025

    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·June 13, 2018

    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

    FDA Enforcement
    Class I ·Terminated·MEDTECH SAS·November 13, 2019

    ROSA One 3.1 Brain Application

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020

    ROSA Brain 3.0 Application-Brain

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020

    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

    FDA Enforcement
    Class I ·Ongoing·MEDTECH SAS·November 3, 2021

    ROSA ONE

    FDA Adverse Event
    Malfunction ·MEDTECH SAS·Product code HAW·June 30, 2021

    ROSA ONE

    FDA Adverse Event
    Malfunction ·MEDTECH SAS·Product code HAW·November 3, 2021

    ROSA ONE

    FDA Adverse Event
    Injury ·MEDTECH SAS·Product code HAW·December 22, 2021

    ROSA ONE

    FDA Adverse Event
    Malfunction ·MEDTECH SAS·Product code HAW·April 8, 2022

    ROSA ONE

    FDA Adverse Event
    Malfunction ·MEDTECH SAS·Product code HAW·April 4, 2022

    ROSA ONE

    FDA Adverse Event
    Malfunction ·MEDTECH SAS·Product code HAW·June 2, 2022

    ROSA ONE

    FDA Adverse Event
    Injury ·MEDTECH SAS·Product code HAW·April 11, 2022

    ROSA ONE

    FDA Adverse Event
    Injury ·MEDTECH SAS·Product code HAW·May 9, 2022

    ROSA ONE BRAIN

    FDA Adverse Event
    Injury ·MEDTECH SAS·Product code HAW·July 9, 2024

    ROSA ONE (JP)

    FDA Adverse Event
    Injury ·MEDTECH SAS·Product code HAW·July 11, 2024