Medical Device Manufacturer · GB , Carmarthenshire

The Magstim Company Limited - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2024
3
Total
3
Cleared
0
Denied

The Magstim Company Limited, is a neurotechnology company specializing in brain stimulation and neurophysiological monitoring solutions. Based in Carmarthenshire, GB, Magstim develops and manufactures transcranial magnetic stimulation (TMS), electroencephalography (EEG), and transcranial direct current stimulation (tDCS) systems for clinical and research applications.

The company has received 3 FDA 510(k) clearances from 3 total submissions, with all submissions resulting in clearance. Magstim's cleared devices span neurology and physical medicine categories, with the most recent clearance in 2025. The company maintains active regulatory status and continues to innovate in neuromodulation technologies.

Magstim's product portfolio includes the Horizon® 3.0 TMS Therapy System for neurological treatment and the Rapid2 Magnetic Stimulators series for physical medicine applications. The company also offers integrated multi-modal solutions combining TMS, EEG, and tDCS for comprehensive brain function assessment. With over 30 years of industry experience and more than 20,000 clinical citations, Magstim serves researchers and clinicians across 115+ regions globally.

Explore the complete list of cleared device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - The Magstim Company Limited
3 devices
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