13 results
·
67ms
·
Sources: EU EUDAMED, US FDA
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
QbD RepS BV
Authorized representative
🇧🇪 Belgium·86 Manufacturers·1555 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices