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

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    NeuroQuant

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNITED STEM, PSA TYPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·October 14, 2014

    STAR S4-IR-CE EXCIMER LASER

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LZS·June 14, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    TASUKI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·June 6, 2019

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·January 2, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·January 2, 2020

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020