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

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    COLUMNMATE(TM) BETA-THAL CAT. NO. 4515

    FDA 510(k)
    FDA Class 2 ·Hematology

    SHARGHP A.V. FISTULA NEEDLE SET

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

    EXTERNAL FIXATOR ST.A R 90 F4

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 14, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 3, 2010

    AUTOSONIX

    FDA Adverse Event
    Malfunction ·COVIDIEN , INC·Product code LFL·December 14, 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