2 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code LXH·October 16, 2009
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Recall
Terminated
·ITC-Nexus Dx·Product code GFO·December 19, 2013