BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    ST AIA-PACK DHEA-S CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HI-WAVE; POUR-PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    VIPER F2 FACET FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    TECNIS 1-PIECE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·September 23, 2014

    DUROM US ACETABULAR COMPONENT 58/52 R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 24, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021