BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    FemChec Controlled Saline-Air Device (FCD-250)

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

    Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    FDA Adverse Event
    Malfunction ·REYNOSA MFG.·Product code FKX·August 19, 2011

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FNL·November 10, 2014

    PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·July 22, 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