Iradimed Corporation - FDA 510(k) Cleared Devices
Recent clearances: MRidium 3870 MRI Infusion Pump System (3870), 3880 MRI Patient Monitoring System, 3880 MRI Patient Monitoring System
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iradimed Corporation General Hospital ✕
4 devices
Cleared
May 28, 2025
MRidium 3870 MRI Infusion Pump System (3870)
General Hospital
258d
Cleared
Dec 15, 2016
MRidium 3860+ MRI infusion Pump/ Monitoring System
General Hospital
751d
Cleared
Apr 07, 2009
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
General Hospital
84d
Cleared
Mar 24, 2005
MRIDIUM 3850 MRI PUMP SYSTEM
General Hospital
44d