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

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    Disposable Insulin Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP.·Product code NIQ·August 4, 2006

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018