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

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    USI DENTAL POLISHER. A/G-20

    FDA 510(k)
    FDA Class 1 ·Dental

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228731471·GC Initial™ AL Inside IN-47 Sienna, 20g

    SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SuperNO2VA Et Device

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·June 13, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·October 14, 2010

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ILJ·December 13, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014