# Iradimed Corporation (manufacturer, Orlando, FL): 3 new FDA device listings, incl. set, i.v. fluid transfer

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Iradimed Corporation |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Orlando, FL, US |
| New listings | 3 |
| Devices | Set, I.V. Fluid Transfer; Stand, Infusion; Pump, Infusion |
| Product codes | LHI, FOX, FRN |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital |
| Brand names | 1000 Series IV Sets; 1119 MRI IV Pole; MRidium 3870 MRI Infusion Pump System |
| First new listing | 2026-05-05 |
| Latest new listing | 2026-05-05 |
| FDA registration number | 3005053560 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.