BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    MICRODILUTION GRAM-NEGATIVE ID. PANEL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517120793·Helix-T Plate, 68mm 3-Level

    VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PORTABLE INFANT VENTILATOR

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

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·April 30, 2014

    GATEWAY¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code GBA·October 10, 2012

    QUPID PLUS HCG URINE/SERUM PREGNANCY

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code JHI·July 30, 2010

    Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016