BEUDAMED
    79 results · 20ms · Sources: EU EUDAMED, US FDA

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    X-PSI Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zimmer PSI Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAS PSI KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·December 10, 2014

    Profound Medical Inc.

    Manufacturer
    🇨🇦 Canada·5 Basic UDI-DIs·5 Devices·2 Importers·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Opsens Inc.

    Manufacturer
    🇨🇦 Canada·4 Basic UDI-DIs·4 Devices·4 Importers·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Circle Cardiovascular Imaging Inc

    Manufacturer
    🇨🇦 Canada·6 Basic UDI-DIs·7 Devices·3 Importers·BSI Group The Netherlands B.V., SGS Belgium NV, and BSI Group The Netherlands B.V.

    Intelerad Medical Systems Incorporated

    Manufacturer
    🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    Nuraleve

    Manufacturer
    🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

    Northern Digital Inc.

    Manufacturer
    🇨🇦 Canada·17 Basic UDI-DIs·17 Devices·2 Importers·BSI Group The Netherlands B.V.

    cvi42

    Device
    EU MDD · Eu Md Class 2a ·Circle Cardiovascular Imaging Inc·On the market·1 country

    TULSA-PRO

    Device
    EU MDD · Eu Md Class 2b ·Profound Medical Inc.·On the market·25 countries

    Smartstim M1000

    Device
    EU MDD · Eu Md Class 2a ·Nuraleve·On the market·1 country

    Sonalleve

    Device
    EU MDD · Eu Md Class 2b ·Profound Medical Inc.·On the market·25 countries

    Sonalleve

    Device
    EU MDD · Eu Md Class 2b ·Profound Medical Inc.·On the market·25 countries

    Sonalleve

    Device
    EU MDD · Eu Md Class 2b ·Profound Medical Inc.·On the market·26 countries

    Sonalleve

    Device
    EU MDD · Eu Md Class 2b ·Profound Medical Inc.·On the market·25 countries

    INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

    Device
    EU MDD · Eu Md Class 2b ·Opsens Inc.·On the market·17 countries

    INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

    Device
    EU MDD · Eu Md Class 2b ·Opsens Inc.·On the market·26 countries

    CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC

    Device
    EU MDD · Eu Md Class 3 ·Opsens Inc.·On the market·17 countries