BEUDAMED
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    ACUFEX DREZ COMMUNICATING DRILL GUIDE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CERVICAL PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    IVFLO-HP & IVFIL-HP FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·November 15, 2012

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 10, 2015

    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