4 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.
FDA Recall
Terminated
·Bioplate Inc·Product code JEY·March 31, 2010
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014