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

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    Safety Heel Lancet

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471142646·Ten-Ties, Silver

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383516440·"An absorbent paper points is an endodontic pap...

    AEROECLIPSE II BREATH ACTUATED NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ivWatch Model 400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEN NDL 32G 4MM PRO 14

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 7, 2021

    TELIGEN IS-1/DF-1 - DR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·August 10, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 12, 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