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

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    Endoscope Reprocessor OER-Elite

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOSCOPE REPROCESSOR OER-Elite

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Olympus OER-Elite

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus OER-Pro

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    Olympus OER-Mini

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025

    MHI-TM2000 Linear Accelerator System Product Usage: 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·Hitachi Ltd., Medical System Operations Group·May 9, 2018