BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LCP

    FDA UDI
    Synthes GmbH·10886982166319·3.5MM LCP® POSTEROLATERAL DISTAL HUMERUS PLATE ...

    Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SILVERSITE OR CALGITROL

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACROBAT SUV VACUUM OFF-PUMP SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT CARDIAC SURGERY·Product code MWS·November 21, 2008

    7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 17, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·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