BEUDAMED
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    LATITUDE EV Total Elbow Arthroplasty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FRACTORA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    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