BEUDAMED
    3 results · 11ms · Sources: EU EUDAMED, US FDA

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    i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.

    FDA Recall
    Terminated ·Imaging Sciences International, LLC·Product code JAK·October 30, 2009

    Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.

    FDA Recall
    Terminated ·Imaging Sciences International, LLC·Product code MUH·January 8, 2009

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015