BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    VICTOREEN MODEL 530

    FDA 510(k)
    FDA Class 2 ·Radiology

    GE DELTA SOFTWARE OPTION FOR MRI

    FDA 510(k)
    FDA Class 2 ·Radiology

    Elecsys PTH , Elecsys PTH STAT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·January 28, 2013

    DIRECT CHECK QUALITY CONTROL

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GGN·November 30, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 1, 2014

    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·November 11, 2015

    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code LRO·September 21, 2015