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

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    CLOTH-HYPOALLERGENIC

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DURASUL BIPOLAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPAT ENTERAL DELIVERY PUMP SETS

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

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·February 9, 2024

    UNKNOWN M2A HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014

    TAXUS® EXPRESS²®

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 20, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·September 10, 2010

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014