BEUDAMED
    3 results · 13ms · Sources: EU EUDAMED, US FDA

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    CT 5300; Software Version Number: 4.5, 5.0, 5.1;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 10, 2025

    Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025