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Iradimed Corporation

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest FDA decision2025-05-28
TypeNumberDevice NameCodeDateActions
510(k) K242752 MRidium 3870 MRI Infusion Pump System (3870)FRN2025-05-28 View
510(k) K180903 3880 MRI Patient Monitoring SystemMWI2019-03-29 View
510(k) K182900 3880 MRI Patient Monitoring SystemMWI2018-12-14 View
510(k) K172200 3880 MRI Patient Monitoring SystemMWI2017-10-25 View
510(k) K143369 MRidium 3860+ MRI infusion Pump/ Monitoring SystemFRN2016-12-15 View
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