BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    MX860, REUSABLE PRESSURE TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONIXTOUCH ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COPPER SULFATE SOLUTION SP. GR.1.055

    FDA 510(k)
    FDA Class 1 ·Hematology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·February 7, 2014

    CVC SET: 2-LUMEN 7 FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DQY·October 15, 2010

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code CAC·December 18, 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