The Magstim Company Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0869-2021 | Class II | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for u | December 8, 2020 |
| Z-2884-2020 | Class II | Neurosign V4 Intraoperative Nerve monitor family of devices. | June 23, 2020 |
| Z-1966-2020 | Class II | Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depres | March 23, 2020 |
| Z-1965-2020 | Class II | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Ma | March 23, 2020 |
| Z-0836-2019 | Class II | HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) | October 25, 2018 |
| Z-1352-2018 | Class II | Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid | September 28, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | July 3, 2025 |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 | March 17, 2025 |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 | August 30, 2024 |
| K143531 | Rapid Therapy System | May 8, 2015 |