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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
FDA Enforcement
Class II
·Terminated·Resmed Corporation·February 10, 2016
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
FDA Enforcement
Class II
·Terminated·Resmed Corporation·August 24, 2016
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·January 2, 2013
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
FDA Enforcement
Class II
·Terminated·Besmed Health Business Corporation·October 24, 2018