BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPENCIO SKIN GUARD KIT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO PROLITE PULSED LIGHT SYSTEM

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

    MECTALIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·April 21, 2014

    INSYNC III

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DXY·January 11, 2013

    EON MINI IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 23, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·August 21, 2019

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021