BEUDAMED
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    HISTOPLASMA MYCELIAL ANTIGEN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ortho Specialties

    FDA UDI
    Young Innovations, Inc.·00840326414361·Anatomical Molar Bands, Lower Right 2nd Molars,...

    ULTRAZYME AMYLASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LENS, HARD CONTACT

    FDA 510(k)
    FDA Unclassified ·Unknown

    ALARIS PC UNIT

    FDA Adverse Event
    Injury ·CAREFUSION CORP·Product code FRN·April 7, 2014

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·September 26, 2012

    SALINE BREAST IMPLANTS

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FWM·July 1, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025