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

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    Elucid PlaqueIQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180159020·MULTI FLEX NEURO LASRGE INSTR. HOLDER 1" DIA, ...

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071152680·24F x 1.5cm MiniSPC Low Profile Suprapubic Cath...

    NEURO-AUDIO

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

    GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    1ML BD¿ TUBERCULIN SYRINGE, 27GX1/2" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 20, 2017

    1 ML BD¿ TB SYRINGE WITH 27G X 1/2IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 20, 2016

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·CYTYC SURGICAL PRODUCTS·Product code MNB·November 21, 2008

    LIFEVEST WCD 400 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 10, 2011

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code MCX·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