BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    PROFESSIONAL MARK I BIOFEEDBACK SYS

    FDA 510(k)
    FDA Class 2 ·Neurology

    VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYPERION X9

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMPTY CONTAINER 1-L

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code KPE·March 20, 2014

    COULTER® ACT DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·November 7, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·September 2, 2010

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024