BEUDAMED
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    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.

    Articluated arm clamp base

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Coroneo Inc.·1 device

    ORAcollect (Swab based RNA Collection Device)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·1 device

    ORAgene (Swab-based DNA & Dx Collection Device)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

    ORAcollect (Swab based DNA & Dx Collection Device)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·3 devices

    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017

    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