Iradimed Corporation - FDA 510(k) Cleared Devices

Iradimed Corporation, specializes in MRI-safe medical devices for patient care in magnetic resonance imaging environments. The company develops infusion pumps, patient monitoring systems, and ferrous metal detection solutions designed for use during MRI procedures. Iradimed operates with a manufacturing facility in Winter Park, Florida.

The company maintains a strong FDA 510(k) regulatory record with 7 FDA 510(k) clearances from 7 total submissions since its first clearance in 2005. All submissions have resulted in clearances, with no denials. The latest clearance in 2025 demonstrates continued product innovation and active market presence in MRI-compatible medical devices.

Iradimed's cleared device portfolio focuses on MRI infusion pump systems and MRI patient monitoring systems for general hospital and cardiovascular applications. These devices enable safe medication delivery and vital sign monitoring within the MRI scanner environment, addressing a specialized clinical need in diagnostic imaging.

Explore the company's complete device portfolio, product codes, and clearance dates in the FDA 510(k) database.