5 results
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18ms
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Sources: EU EUDAMED, US FDA
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·June 10, 2015
VECTRA GENISIS
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code GZJ·March 21, 2008
OPTIP 60 REFOBACINE PLUS BONE CMT-3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·August 23, 2019
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
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