2 results
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54ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
FDA Recall
Completed
·Ventana Medical Systems Inc·Product code KPA·October 4, 2019
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
FDA Enforcement
Class II
·Completed·Ventana Medical Systems Inc·June 17, 2020