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

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    QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATLAS CUP METAL BACK III P D.52

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489413667·

    IPACS ORTHO

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIDEO BRONCHOSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD¿ NEEDLE 30X1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY·Product code FMI·December 4, 2019

    KNEE IMPLANT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·November 10, 2014

    INSTATRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·August 17, 2011

    8CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·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