BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    REVISED IMMUDIA HEM-SP

    FDA 510(k)
    FDA Class 2 ·Hematology

    MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    TISSUE MIMICKING ULTRASOUND PHANTOMS

    FDA 510(k)
    FDA Class 1 ·Radiology

    GORE® DUALMESH® PLUS BIOMATERIAL

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code FTL·August 15, 2023

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER

    FDA Adverse Event
    Injury ·Product code HWC·September 16, 2021

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 16, 2014

    INRATIO

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·October 15, 2010

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 14, 2012

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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