5 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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OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·March 7, 2018
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012