3 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025