BEUDAMED
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    DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·February 21, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 28, 2011

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 8, 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