BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Senhance Ultrasonic System

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

    HEARTSUITE HEMODYNAMICS 7.10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 18, 2014

    SPACELABS MCARE VITAL SIGNS MONITOR

    FDA Adverse Event
    SPACELABS HEALTHCARE·Product code MHX·October 20, 2010

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 20, 2012

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015