3 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
FDA Enforcement
Class II
·Ongoing·Medtronic, PLC·March 11, 2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Enforcement
Class II
·Ongoing·Medtronic CoreValve LLC·March 18, 2020
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Enforcement
Class II
·Ongoing·Medtronic CoreValve LLC·March 18, 2020