BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    SnugFit ASA Extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXPASYL POWER APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Dental

    BRX PRO Bruxism Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    CUSTOM KIT

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·November 21, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 25, 2013

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024