BEUDAMED
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    SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984261·anteriors; shade B1; mould 94

    TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROWESS 2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    PUMP,COLLEAGUE SINGLE CHANNELCOLOUR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 10, 2011

    TRIDENT 0 DEG CONSTRAINED INSERT 22E

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWZ·August 6, 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