Iradimed Corporation - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
Iradimed Corporation has 7 FDA 510(k) cleared medical devices. Based in Winter Park, US.
Latest FDA clearance: May 2025. Active since 2005. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Iradimed Corporation Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Iradimed Corporation
7 devices
Cleared
May 28, 2025
MRidium 3870 MRI Infusion Pump System (3870)
General Hospital
258d
Cleared
Mar 29, 2019
3880 MRI Patient Monitoring System
Cardiovascular
357d
Cleared
Dec 14, 2018
3880 MRI Patient Monitoring System
Cardiovascular
59d
Cleared
Oct 25, 2017
3880 MRI Patient Monitoring System
Cardiovascular
96d
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