BEUDAMED
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    BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION HIP STEM WITH ADDITIONAL STEM SIZES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESPE NIMETIC-GRIP

    FDA 510(k)
    FDA Class 2 ·Dental

    SUPERIOR END PLATE MEDIUM 6°-STERILE

    FDA Adverse Event
    Injury ·BRANDYWINE·Product code MJO·February 5, 2013

    TRANSVENOUS

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 3, 2011

    FREESTYLE

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code LFR·July 18, 2014

    SINGLE USE PAPER FILTER WITH INDICATOR

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code FRG·January 30, 2019

    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