BEUDAMED
    9 results · 58ms · Sources: EU EUDAMED, US FDA

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    STEREOTAXIS SYSTEM

    FDA Adverse Event
    Malfunction ·OMEGA MEDICAL IMAGING INC. / STEREOTAXIS, INC.·Product code PJB·November 7, 2025

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    FDA Recall
    Open, Classified ·Omega Medical Imaging, Inc.·Product code IWE·September 8, 2023

    Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

    FDA Recall
    Open, Classified ·Omega Medical Imaging, Inc.·Product code IWE·February 28, 2023

    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

    FDA Recall
    Terminated ·Omega Medical Imaging, Inc.·Product code N/A·June 21, 2016

    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

    FDA Recall
    Terminated ·Omega Medical Imaging, Inc.·Product code IWE·March 23, 2017

    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

    FDA Enforcement
    Class II ·Terminated·Omega Medical Imaging, Inc.·September 14, 2016

    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

    FDA Enforcement
    Class II ·Terminated·Omega Medical Imaging, Inc.·June 28, 2017

    Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

    FDA Enforcement
    Class II ·Ongoing·Omega Medical Imaging, Inc.·November 1, 2023

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    FDA Enforcement
    Class II ·Ongoing·Omega Medical Imaging, Inc.·November 1, 2023