3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
×
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
FDA Enforcement
Class I
·Ongoing·ROi CPS LLC·February 12, 2025
Regard Dressing change kit, Item Number 800026006
FDA Enforcement
Class I
·Terminated·ROi CPS LLC·January 10, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
FDA Enforcement
Class I
·Terminated·ROi CPS LLC·January 24, 2024