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

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    OneStim-DUO Cardiac Stimulator (MP5003-4CO)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

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

    SLACTIVE IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2025

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    GE OEC 2600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·December 9, 2008

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 31, 2011

    DIMENSION RXL MAX WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·July 29, 2013

    PERCLOSE PROGLIDE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·July 14, 2025

    AXIOS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024

    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