3 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code PDJ·October 4, 2016
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LCP·October 4, 2016
Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, " Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. " Olecranon and proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HRS·September 28, 2015