Iradimed Corporation
Iradimed Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2025, with 3 FDA device recalls on record.
Top product codes for Iradimed Corporation
FDA recalls by Iradimed Corporation
- Z-1310-2023 — Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
- Z-1874-2013 — MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
- Z-0446-2013 — The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Iradimed Corporation
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
- K180903 — 3880 MRI Patient Monitoring System
- K182900 — 3880 MRI Patient Monitoring System
- K172200 — 3880 MRI Patient Monitoring System
- K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System
- K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
- K050301 — MRIDIUM 3850 MRI PUMP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.