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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories Inc. (St Jude Medical)·June 23, 2021

    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