BEUDAMED
    5 results · 7ms · Sources: EU EUDAMED, US FDA

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    IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

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

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Enforcement
    Class II ·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022

    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

    FDA Enforcement
    Class II ·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022

    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

    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Enforcement
    Class II ·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022