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

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    DU PONT ANALYST THYROID ROTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VOLUMATIC

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OP-CON SURGICAL INSTRUMENT #9

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 19, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·October 27, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 21, 2012

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021