BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYMCARE DIABETES MANAGEMENT PROGRAM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 27, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 1, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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