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

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    IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC

    FDA 510(k)
    FDA Class 2 ·Immunology

    NYCOPLASTIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE-NORTH AMERICA·Product code KDI·May 16, 2008

    BASIS¿ SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code MCX·December 14, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 10, 2014

    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 30, 2014