BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Coude Sleeved IC; Coude Plus Sleeved IC

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

    TandemLung Oxygenator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 31, 2023

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 7, 2014

    AEM SUCTION IRRIGATION ELECTRODE, SPATULA

    FDA Adverse Event
    Malfunction ·ENCISION INC.·Product code GEI·August 3, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 29, 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