BEUDAMED
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    Best Theratronics Ltd.

    FDA registration
    Best Theratronics Ltd.·4 products·🇨🇦 Canada

    Bundle - One-On-One Studio Starter 2ST-11001

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·21 countries

    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.

    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.

    FDA Enforcement
    Class II ·Terminated·BEST THERATRONICS LTD.·August 3, 2016

    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017

    Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C

    FDA Enforcement
    Class II ·Ongoing·AMD Medicom Inc.·June 24, 2026

    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