BEUDAMED
    24 results · 48ms · Sources: EU EUDAMED, US FDA

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    THERMIRF

    FDA Adverse Event
    Injury ·SPINESMITH HOLDINGS,LLC·Product code DWG·November 19, 2023

    THERMIGEN

    FDA Adverse Event
    Injury ·SPINESMITH HOLDING, LLC·Product code GEI·November 17, 2023

    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

    FDA Recall
    Terminated ·Spine Smith Holdings, LLC·Product code MAX·July 31, 2013

    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

    FDA Enforcement
    Class II ·Terminated·Spine Smith Holdings, LLC·September 25, 2013