3 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
T:slim Insulin Delivery System Insulin Infusion Pump
FDA Enforcement
Class I
·Terminated·Tandem Diabetes Care Inc·February 19, 2014
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025