BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    CHRONOCOR VI MODEL 5012

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROUND STAPLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPOON FORCEPS, 11MM

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

    NEURON DELIVERY CATHETER 070

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code DQY·November 3, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 7, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·December 28, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015