2 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
FDA Enforcement
Class I
·Ongoing·Getinge Usa Sales Inc·August 31, 2022
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
FDA Enforcement
Class I
·Terminated·Thoratec Corporation·May 31, 2017