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

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    OPHTHALMIC TIP & BLADE SCALPELS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740571·GC Initial™ Ti Dentin DB2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556703981·GC Initial™ AL Enamel Intensive EI-12, 20g

    IL 301 PORTABLE TRANSCUT. OXYGEN MONI

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    C-22 PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    PB540 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·May 28, 2014

    TRANSVENOUS

    FDA Adverse Event
    Malfunction ·HISTORICAL CPI ST. PAUL·Product code NVN·October 19, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 14, 2012

    Pipeline Flex Embolization Device

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