5 results
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131ms
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Sources: EU EUDAMED, US FDA
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·July 18, 2012
TRUDI SUCTION, 70 - 1PK
FDA Adverse Event
Malfunction
·ACCLARENT, INC.·Product code PGW·January 2, 2024
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code LLZ·September 15, 2006
VTI ENTRAK
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION, INC.·Product code IZL·September 13, 2005
VTI ENTRAK
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION, INC.·Product code IZL·September 13, 2005