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

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    Filters Classification: Class Ii ×

    GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024