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

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    CareSuperb™ COVID-19 Antigen Home Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Disposable Hemodialysis Access Catheter Set

    FDA UDI
    Guangdong Baihe Medical Technology Co., Ltd.·06938634469709·

    Disposable Hemodialysis Access Catheter Set Double Lumen14F*15cm(Cruved)

    FDA UDI
    Guangdong Baihe Medical Technology Co., Ltd.·06938634496354·

    HEMO-DOP

    FDA 510(k)
    FDA Class 2 ·Radiology

    GenesisZr 4Y+ (ST1100) Zirconia

    FDA 510(k)
    FDA Class 2 ·Dental

    CLINICAL INFORMATION CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·November 19, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    2520274-2013-04580

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·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