BEUDAMED
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    GENERAL EQUIPMENT COVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MR 7700

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838115668·MR 7700 extends the gradient and RF designs wit...

    ULTRACHEM TOTAL PROTEIN, #64974

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DUAL CHANNEL PULSE HEIGHT ANALYZER

    FDA 510(k)
    FDA Class 1 ·Radiology

    EBI SPINELINK - II SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code NKB·April 30, 2014

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    FDA Adverse Event
    Injury ·CAREFUSION CORP·Product code FPA·October 3, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Malfunction ·Product code FKX·August 3, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Assurity MRI Model Numbers: PM1272, PM2272 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