BEUDAMED
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    LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UREA AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HYPODERMIC SYRINGES & NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. SHANGHAI·Product code INI·June 19, 2014

    UNK COONRAD/MORREY HUMERAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·October 19, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·December 22, 2012

    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