3 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·August 3, 2022
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·July 21, 2021
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·March 30, 2022