5 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·November 26, 2025
BrightView XCT, Gamma Camera, Product Code 882482
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
FDA Enforcement
Class II
·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
Xhibit Telemetry Receiver, Model: 96280
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022