BEUDAMED
    147 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    IMACTIS SAS

    Manufacturer
    🇫🇷 France·3 Basic UDI-DIs·3 Devices

    IMACTIS SAS

    Manufacturer
    🇫🇷 France

    IMACTIS, SAS

    FDA registration
    IMACTIS, SAS·2 products·🇫🇷 France

    IMACTIS®

    FDA UDI
    IMACTIS·B681J020000·Navigation station of the IMACTIS® CT-NAVIGATIO...

    IMACTIS®

    FDA UDI
    IMACTIS·B681J00099US0·Power cable of the IMACTIS® CT-NAVIGATION system

    IMACTIS®

    FDA UDI
    IMACTIS·B681A102001·Non-sterile needle holder of the IMACTIS® CT-NA...

    IMACTIS®

    FDA UDI
    IMACTIS·B681A100101·Sterile needle holder of the IMACTIS® CT-NAVIGA...

    IMACTIS®

    FDA UDI
    IMACTIS·B681J001971·Transport suitcase for the navigation station o...

    IMACTIS®

    FDA UDI
    IMACTIS·B681J000970·Cart for the IMACTIS® CT-NAVIGATION system

    IMACTIS®

    FDA UDI
    IMACTIS·B681I101002·Single use Navigation Kit of the IMACTIS® CT-NA...

    Needle Holder (Not sterile)

    Device
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·On the market·13 countries

    Needle Holder

    Device
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·On the market·12 countries

    IMACTIS Navigation station

    Device
    EU MDR · Eu Md Class 2b ·IMACTIS SAS·On the market·15 countries

    IMACTIS CT-Navigation system

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMACTIS® NaviKit™

    Device
    EU MDR · Eu Md Class 2a ·On the market

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    FDA Recall
    Open, Classified ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·August 1, 2019

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    FDA Recall
    Terminated ·Imactis 20 Rue Du Tour De L Eau St Martin D Heres France·Product code JAK·February 11, 2021

    IMACTIS non sterile needle holder

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·1 device

    IMACTIS sterile needle holder

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·IMACTIS SAS·1 device

    IMACTIS® Navigation Station

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·IMACTIS SAS·1 device