BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEEDLE-TRAP/NEEDLE SAFETY LABEL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEKURE HbA1c Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KNT·April 17, 2020

    FREESTYLE

    FDA Adverse Event
    Malfunction ·Product code LFR·June 13, 2014

    BLOOD SET 4MM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code BRZ·October 18, 2010

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CFR·December 13, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017