BEUDAMED
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    LIBERTY RECTAL PELVIC FLOOR EXERCISER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOTRACHEAL TUBE HOLDER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UNKNOWN PRODUCT - SET SCREW

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·February 15, 2013

    ADVANTA

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 22, 2010

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 29, 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