Company · GB
The Magstim Company , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2025. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2025 | K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) The Magstim Company Limited, GB | QPL |
| Mar 17, 2025 | K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); The Magstim Company Limited, GB | OBP |
| Aug 30, 2024 | K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); The Magstim Company Limited, GB | OBP |
| Oct 25, 2023 | K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 w The Magstim Company , Ltd., GB | OBP |
| Mar 16, 2023 | K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ Magstim Company, Ltd., GB | OBP |
| Jan 13, 2023 | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ Magstim Company, Ltd., GB | OBP |
| Sep 14, 2021 | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation Magstim Company, Ltd., GB | OBP |
| Mar 17, 2021 | K203684 | Neurosign V4 Intraoperative Nerve Monitor Magstim Company, Ltd., GB | PDQ |
| Apr 3, 2019 | K183376 | HORIZON TMS Therapy System with Navigation Magstim Company, Ltd., GB | OBP |
| Mar 15, 2019 | K182853 | HORIZON TMS Therapy System Magstim Company, Ltd., GB | OBP |
| Nov 9, 2018 | K181559 | Neurosign V4 Intraoperative Nerve Monitor Magstim Company, Ltd., GB | PDQ |
| Aug 3, 2018 | K180907 | HORIZON TMS Therapy System Magstim Company, Ltd., GB | OBP |
| Sep 13, 2017 | K171051 | HORIZON Therapy System Magstim Company, Ltd., GB | OBP |
| Mar 10, 2017 | K162935 | Rapid2 Therapy System Magstim Company, Ltd., GB | OBP |
| May 8, 2015 | K143531 | Rapid Therapy System Magstim Company Limited, GB | OBP |
| Aug 23, 2013 | K130403 | MAGSTIM DOUBLE 70-2 COIL The Magstim Company , Ltd. | GWF |
| Jul 29, 2009 | K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Dec 8, 2008 | K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 The Magstim Company , Ltd., GB | GWF |
| Dec 12, 2007 | K071349 | NEUROSIGN LARYNGEAL ELECTRODES The Magstim Company , Ltd., GB | ETN |
| Dec 21, 2005 | K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 The Magstim Company , Ltd., GB | GWF |
| Dec 14, 2005 | K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 The Magstim Company , Ltd., GB | ETN |
| May 19, 1999 | K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd. | ETN |
| Aug 5, 1998 | K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| May 14, 1997 | K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Jun 2, 1995 | K945799 | NEUROSIGN 100 IMPEDANCE METER The Magstim Company , Ltd., GB | ETN |
| May 9, 1995 | K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR The Magstim Company , Ltd., GB | ETN |
| Nov 24, 1992 | K923056 | NEUROSIGN MODEL 100 The Magstim Company , Ltd., GB | ETN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2020 | The Magstim Company Limited Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT Terminated |
ETN | K923056 |
| Jun 23, 2020 | The Magstim Company Limited Neurosign V4 Intraoperative Nerve monitor family of devices. Terminated |
PDQ | K181559 |
| Mar 23, 2020 | The Magstim Company Limited Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antid Terminated |
OBP | K051864 K143531 +4 |
| Mar 23, 2020 | The Magstim Company Limited Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from p Terminated |
OBP | K051864 K143531 +4 |
| Oct 25, 2018 | The Magstim Company Limited HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) Open, Classified |
OBP | K180907 |
| Sep 28, 2017 | The Magstim Company Limited Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters
Product Usage For the treatment of major depressive Terminated |
OBP | K143531 K162935 |