BEUDAMED
    2 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    RT-5100 Refractor, a component of the Epic-5100 System.

    FDA Enforcement
    Class III ·Terminated·Nidek Inc.·December 26, 2018

    NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

    FDA Enforcement
    Class III ·Terminated·Nidek, Inc.·January 8, 2020