4 results
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78ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
FDA Enforcement
Class II
·Terminated·Getinge Group Logistics America, LLC·March 17, 2021
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
FDA Enforcement
Class II
·Ongoing·Getinge Group Logistics America, LLC·October 21, 2020
Operating Table System
FDA Enforcement
Class II
·Ongoing·Getinge Group Logistics America, LLC·March 31, 2021
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure.
FDA Enforcement
Class II
·Terminated·Getinge Group Logistics America, LLC·February 24, 2021