BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    SERIES I/S INFECTIONS

    FDA 510(k)
    FDA Class 2 ·Immunology

    CONTINU-FLO SOLUTION ADMIN. 2C9102

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LYSE-TEC

    FDA 510(k)
    FDA Class 1 ·Hematology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 2, 2014

    ACCUSTAT, SINGLE FIBER (AURA/ORION)

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·November 8, 2012

    DOUBLE-HEADER

    FDA Adverse Event
    Malfunction ·US ENDOSCOPY·Product code FEB·September 3, 2010

    PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014