2 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco Corporation·Product code DZC·March 15, 2011
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Enforcement
Class II
·Terminated·Tenex Health Inc·May 14, 2014