BEUDAMED
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    BioHorizons CAD/CAM Bars

    FDA 510(k)
    FDA Class 2 ·Dental

    DORIPENEM 10UG BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·June 20, 2013

    LH700 SERIES DILUENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GIF·July 1, 2011

    SYNERGY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 29, 2008

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014