BEUDAMED
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    700-F SERIES STIMULATION ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HCL LABORATORY SYSTEMS 200 -LISA-

    FDA Adverse Event
    Other ·HYCEL DIAGNOSTICS·Product code JJF·November 8, 2000

    CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EYEOPENER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·June 19, 2014

    REVO MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·February 15, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 19, 2011

    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