2 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014