BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Etiometry Platform (DAV 5.4 RAE 9.2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DemeMASK

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

    KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOVOPEN 3

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S - MEDICAL SYSTEMS·Product code FMF·April 19, 2005

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 4, 2020

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 4, 2024

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 4, 2024

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·August 19, 2011

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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