4 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
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