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

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    EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PLATEAU SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOSORBFX O/M 2.0/2/4 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·June 26, 2014

    PFC SIGMA C/S NPOR FEM LT SZ 4

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC·Product code JWH·November 29, 2010

    UNKNOWN DEPUY POLY ACETABULAR LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·January 11, 2013

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021