BEUDAMED
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    BENNETT X-RAY ID PLUS

    FDA 510(k)
    FDA Class 1 ·Radiology

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9253320·

    MODEL 795 FLUOROMETER/DENSITOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEART NUBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DRILL, AO, STERILE T2 FEMUR 4,2X340 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HTW·December 18, 2012

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·January 17, 2013

    ZEPHYR XL SR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 15, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·December 14, 2010

    EPIK UNI KNEE

    FDA Adverse Event
    Injury ·ENCORE MEDICAL L.P.·Product code HRY·October 18, 2017

    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