3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025