3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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MAGNETOM Verio Dot. Model Number: 10684333.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
FDA Enforcement
Class I
·Terminated·Focus Diagnostics Inc·April 13, 2016
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
FDA Enforcement
Class I
·Terminated·Focus Diagnostics Inc·April 13, 2016