BEUDAMED
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    REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012

    DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·January 18, 2013

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 9, 2014

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017