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

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    IMPALA AXLES

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)

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

    ECHOSTAR SPICA 1.5T MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COROX OTW-S 75-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NKE·November 24, 2010

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 21, 2012

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·April 21, 2020

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 20, 2013