3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
FDA Enforcement
Class I
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 2, 2016
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·May 28, 2014