BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    BodyTom 64

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIVOSORB SHEET, MODEL FS01

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    OT ULTRA2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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