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

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    Filters Regulation: Us FDA ×

    Pro M Class

    FDA 510(k)
    FDA Class 1 ·Dental

    K SERIES CPAP SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 24, 2022

    TENDRIL ST

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·October 30, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·August 17, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019