BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    Fast PCR Mini Respiratory Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BlastGen

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CRYPTOSPORIDIUM II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PERSONA PEGGED POROUS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code OIY·November 12, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 12, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 29, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

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