4 results
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33ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·November 13, 2024
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
FDA Enforcement
Class II
·Terminated·Epocal Inc·July 25, 2012