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Sign in to claim this brandIradimed Corporation
US
Last updated September 17, 2026
About
IRadimed is the only company dedicated exclusively to MRI-compatible IV infusion and patient monitoring. Purpose-built for the MRI suite. Trusted by leading hospitals nationwide.
From the manufacturer's own website. Source
What Iradimed Corporation makes
The company manufactures single-use and reusable blood pressure cuffs for clinical and patient monitoring, as well as reusable electrical connection cables for medical devices. It also produces MRI-compatible physiologic monitoring systems, including invasive blood pressure modules and nasal oxygen cannulas with carbon-dioxide sampling capabilities. Additional offerings include single-use pulse oximeter probes and electric infusion pump administration sets.
These devices are classified under FDA regulations as Class I and Class II, with some authorised through the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Iradimed Corporation manufacture?
Iradimed Corporation produces a range of medical devices primarily focused on patient monitoring and infusion systems. These include single-use and reusable blood pressure cuffs for clinical and patient monitoring, reusable electrical connection cables for medical devices, and MRI-compatible physiologic monitoring systems. The latter category includes invasive blood pressure monitoring modules, nasal oxygen cannulas with carbon-dioxide sampling, and pulse oximeter probes. The company also manufactures electric infusion pump administration sets, which are designed for single-use applications.
Where is Iradimed Corporation based?
Iradimed Corporation is headquartered in the United States. The company’s focus on MRI-compatible and infusion-related devices suggests a strong emphasis on serving specialized medical environments, particularly MRI suites.
Which regulatory registries or databases list Iradimed Corporation’s devices?
Iradimed Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. Some of its products are also authorised through the FDA’s 510(k) pathway, which is a premarket submission required for certain Class II devices to demonstrate substantial equivalence to a legally marketed predicate device.
How are Iradimed Corporation’s devices classified under FDA regulations?
Iradimed Corporation’s devices fall under two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal potential risk and are subject to general controls, while Class II devices require additional regulatory controls due to moderate risk. The classification is determined by factors like the device’s intended use, potential harm, and the duration of use, ensuring appropriate oversight based on risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 12705 Ingenuity Dr, Orlando, FL, 32826
- Website
- www.iradimed.com
- linkedin.com/company/iradimed
- facebook.com/iradimed.corp
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005053560
- DUNS Number
- —
Catalogue (83)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Iradimed | 1832SA | FDA UDI | Class II | Active |
| Iradimed | 1834SA-10 | FDA UDI | Class II | Active |
| Iradimed | 1832I | FDA UDI | Class II | Active |
| Iradimed | 3882 | FDA UDI | Class II | Active |
| Iradimed | 1056 | FDA UDI | Class II | Active |
| Iradimed | 3883-1 | FDA UDI | Class II | Active |
| Iradimed | 1888 | FDA UDI | Class II | Active |
| Iradimed | 1883 | FDA UDI | Class II | Active |
| Iradimed | 3883-3 | FDA UDI | Class II | Active |
| Iradimed | 1887 | FDA UDI | Class II | Active |
| Iradimed | 3883-2 | FDA UDI | Class II | Active |
| Iradimed | 1195 | FDA UDI | Class II | Active |
| Iradimed | 1119M | FDA UDI | Class I | Active |
| Iradimed | 1832P | FDA UDI | Class II | Active |
| Iradimed | 1833N1-10 | FDA UDI | Class II | Active |
| Iradimed | 1834C-10 | FDA UDI | Class II | Active |
| Iradimed | 1851 | FDA UDI | Class II | Active |
| Iradimed | 3886 | FDA UDI | Class II | Active |
| Iradimed | 1833N3-10 | FDA UDI | Class II | Active |
| Iradimed | 1822A-25 | FDA UDI | Class II | Active |
| Iradimed | 3880-3 | FDA UDI | Class II | Active |
| Iradimed | 1811 | FDA UDI | Class II | Active |
| Iradimed | 1861 | FDA UDI | Class II | Active |
| Iradimed | 3865 | FDA UDI | Class II | Active |
| Iradimed | 1841-25 | FDA UDI | Class II | Active |
| Iradimed | 1862 | FDA UDI | Class II | Active |
| Iradimed | 1812-25 | FDA UDI | Class II | Active |
| Iradimed | 1822N-25 | FDA UDI | Class II | Active |
| Iradimed | 1832A | FDA UDI | Class II | Active |
| Iradimed | 3880 | FDA UDI | Class II | Active |
| Iradimed | 1058 | FDA UDI | Class II | Active |
| Iradimed | 3885B | FDA UDI | Class II | Active |
| Iradimed | 1822I-25 | FDA UDI | Class II | Active |
| Iradimed | 1832LA | FDA UDI | Class II | Active |
| Iradimed | 1833N4-10 | FDA UDI | Class II | Active |
| Iradimed | 1845-25 | FDA UDI | Class II | Active |
| Iradimed | 1145 | FDA UDI | Class II | Active |
| Iradimed | 1121 | FDA UDI | Class II | Active |
| Iradimed | 3860+ | FDA UDI | Class II | Active |
| Iradimed | 3883 | FDA UDI | Class II | Active |
| Iradimed | 1054 | FDA UDI | Class II | Active |
| Iradimed | 3880-4 | FDA UDI | Class II | Active |
| Iradimed | 1844A-25 | FDA UDI | Class II | Active |
| Iradimed | 1833N2-10 | FDA UDI | Class II | Active |
| Iradimed | 3861 | FDA UDI | Class II | Active |
| Iradimed | 1119 | FDA UDI | Class I | Active |
| Iradimed | 1843P-25 | FDA UDI | Class II | Active |
| Iradimed | 1120 | FDA UDI | Class II | Active |
| Iradimed | 1822P-25 | FDA UDI | Class II | Active |
| Iradimed | 1834AL-10 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Iradimed Corporation has three FDA recall records initiated between August 24, 2012, and February 24, 2023, with statuses including open, classified, and terminated. The recalls involve issues with syringe adapter sets (defective injection-molded parts affecting venting), non-specified compliance for MRidium Series 1000 infusion sets, and incorrect rate values in the Dose Error Reduction System (DERS) during initial setup.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 24, 2023 | Z-1310-2023 | — | open, classified | Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion. |
| Jul 1, 2013 | Z-1874-2013 | — | terminated | The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value. |
| Aug 24, 2012 | Z-0446-2013 | — | terminated | Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications. |