BEUDAMED
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    WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Dental

    QSC-127-INT SHOULDER ARRAY COIL SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRUEPATH CTO DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 38 CM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·May 20, 2021

    AQUACEL AG - SURGICAL COVER DRESSINGS

    FDA Adverse Event
    Injury ·CONVATEC INC·Product code FRO·June 19, 2014

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·February 2, 2013

    PIONEER MATTRESS 30"

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code IKY·December 9, 2010

    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