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Iradimed Corporation

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
7
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1310-2023Class IIIradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, February 24, 2023
Z-1874-2013Class IMRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860July 1, 2013
Z-0446-2013Class IIThe brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG0August 24, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K242752MRidium 3870 MRI Infusion Pump System (3870)May 28, 2025
K1809033880 MRI Patient Monitoring SystemMarch 29, 2019
K1829003880 MRI Patient Monitoring SystemDecember 14, 2018
K1722003880 MRI Patient Monitoring SystemOctober 25, 2017
K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemDecember 15, 2016
K090087MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEMApril 7, 2009
K050301MRIDIUM 3850 MRI PUMP SYSTEMMarch 24, 2005