BEUDAMED
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    Resitu Medical AB

    Manufacturer
    🇸🇪 Sweden

    RESITU MEDICAL AB

    FDA registration
    RESITU MEDICAL AB·1 product·🇸🇪 Sweden

    OLYMPUS

    FDA Adverse Event
    Malfunction ·KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD·Product code FEM·August 14, 2015

    GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Recall
    Terminated ·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·November 26, 2014

    GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Enforcement
    Class II ·Terminated·Getinge Disinfection Ab·December 31, 2014