BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GE VIVID 7 BT04

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIRCO OSCILLATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·September 2, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·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