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

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    EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ease-in-Shields™

    FDA UDI
    METREX RESEARCH, LLC·00850036373858·Ease-in-Shields™ grey-blue Solea

    GE 8CH FOOT ANKLE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

    FDA 510(k)
    FDA Class 2 ·Neurology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

    AXIUM 3-D DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·August 25, 2011

    BATT-HANDPIECE MOD F/TRS

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code GEY·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