BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    AUTO REF/KERATOMETER ARK-1e

    Device
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·On the market·32 countries

    AUTO REF/KERATOMETER ARK-1s

    Device
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·On the market·32 countries

    AUTO REF/KERATOMETER ARK-F

    Device
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·On the market·32 countries

    AUTO REF/KERATOMETER ARK-1a

    Device
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·On the market·32 countries

    AUTO REF/KERATOMETER ARK-1

    Device
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·On the market·32 countries

    ARK-1,ARK-1a,ARK-1s,ARK-1e,ARK-F,HandyRef-K

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·6 devices

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·September 24, 2014

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·March 30, 2016

    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·April 6, 2016

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·May 13, 2015

    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·August 14, 2013