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

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    CREATINE PHOSPHOKINASE (CPK)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PIONEER LOWTOP SPINAL ROD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mission Lipid Panel Monitoring System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 10, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 16, 2007

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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