BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    POWERNEB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210519640·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    INSIGHT MILLENNIUM PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    HEARTSTREAM XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2008

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010

    FATHOM GUIDEWIRE

    FDA Adverse Event
    Injury ·SALT LAKE CITY·Product code DQX·February 23, 2010

    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