BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    QUIKPAC-II ONE STEP PREGNANCY HOME TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PERMACEM / PERMACEM DUAL

    FDA 510(k)
    FDA Class 2 ·Dental

    4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·December 2, 2010

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 11, 2013

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2014

    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