Iradimed Corporation
Medical device manufacturer in Winter Springs, FL.
7510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | 05/28/2025SE |
| K180903 | 3880 MRI Patient Monitoring SystemMWI · Traditional | 03/29/2019SE |
| K182900 | 3880 MRI Patient Monitoring SystemMWI · Traditional | 12/14/2018SE |
| K172200 | 3880 MRI Patient Monitoring SystemMWI · Traditional | 10/25/2017SE |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring SystemFRN · Traditional | 12/15/2016SE |
| K090087 | Mridium 3860 MRI Infusion Pump/Monitoring SystemFRN · Traditional | 04/07/2009SE |
| K050301 | Mridium 3850 MRI Pump SystemFRN · Traditional | 03/24/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1310-2023 Class II | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe…Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating… | 02/24/2023Open, Classified |
| Z-1874-2013 Class I | MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the…The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a… | 07/01/2013Terminated |
| Z-0446-2013 Class II | The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set…Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot… | 08/24/2012Terminated |