BEUDAMED
    3 results · 47ms · Sources: EU EUDAMED, US FDA

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    Focalyx Fusion

    FDA UDI
    Focalyx Technologies, LLC·00860003552001·The Focalyx Fusion system is designed for the f...

    Focalyx Fusion

    FDA Recall
    Open, Classified ·Focalyx Technologies, LLC.·Product code LLZ·December 23, 2025

    Focalyx Fusion

    FDA Enforcement
    Class II ·Ongoing·Focalyx Technologies, LLC.·February 11, 2026