BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM

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

    TRACOE silcosoft Tracheostomy Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BLACKMAX-NEURO

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBB·June 13, 2014

    SARNS CENTRIFUGAL PUMP

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code KFM·October 11, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012

    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