BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    MICRO STIX #011-010-5000 & HOLDER#5100

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GISH ARTERIAL FILTER WITH GBS COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 29, 2012

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 2, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·September 2, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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