BEUDAMED
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    PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENCORE SM

    FDA 510(k)
    FDA Class 2 ·Immunology

    PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 14, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 22, 2013

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·July 10, 2014

    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