| MagVenture Accelerated TMS (aTMS) Therapy System (K260189) | Tonica Elektronik A/S | 2026-05-22 |
| Apollo TMS Therapy System;Apollo light TMS Therapy System (K260560) | Mag & More GmbH | 2026-05-22 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K253098) | Nexstim Oyj | 2026-03-20 |
| Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (K252358) | Nexstim Oyj | 2026-03-20 |
| SPRY TMS Therapy System (0550) (K251653) | Soterix Medical, Inc. | 2026-02-20 |
| BrainsWay Deep TMS System (K251391) | Brainsway , Ltd. | 2025-11-07 |
| CloudTMS Edge (K250689) | Teleemg, LLC | 2025-09-14 |
| BrainsWay Deep TMS System (K251449) | Brainsway , Ltd. | 2025-09-13 |
| Apollo TMS Therapy System (K243700) | Mag & More GmbH | 2025-09-04 |
| Apollo TMS Therapy System (K243539) | Mag & More GmbH | 2025-08-18 |
| MagVenture TMS Therapy System (K251125) | Tonica Elektronik A/S | 2025-08-11 |
| MagVenture TMS Therapy System (K251119) | Tonica Elektronik A/S | 2025-08-08 |
| T65 (9016E061-) (K252032) | Tonica Elektronik A/S | 2025-07-30 |
| Ampa One System (AMPA-001) (K251210) | Neuromodulatory Devices & Applications | 2025-06-27 |
| Ultimate rTMS (K243460) | Brain Ultimate, Inc. | 2025-04-17 |
| Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (K243869) | The Magstim Company Limited | 2025-03-17 |
| Ampa One System (AMPA-001) (K243319) | Neuromodulatory Devices & Applications | 2025-02-13 |
| Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) (K241518) | The Magstim Company Limited | 2024-08-30 |
| Deep TMS System (K222196) | Brainsway , Ltd. | 2024-05-31 |
| Apollo TMS Therapy System (K232639) | Mag & More GmbH | 2024-05-24 |
| NeuroStar Advanced Therapy System (All previously cleared models) (K231926) | Neuronetics, Inc. | 2024-03-22 |
| ZapStim Controller Application (Z1023) (K233631) | Revital Lab, Inc. | 2024-02-09 |
| NQ TMS for MDD (NQv1-MU-01) (K232688) | Neuroqore, Inc. | 2023-12-29 |
| NeuroStar Advanced Therapy System (Version 3.8) (K233621) | Neuronetics | 2023-12-13 |
| Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro (K232235) | The Magstim Company , Ltd. | 2023-10-25 |
| Ultimate rTMS; Yingchi rTMS (K230735) | Brain Ultimate, Inc. | 2023-09-13 |
| NeuroStar Advanced Therapy System (Version 3.7) (K230029) | Neuronetics | 2023-04-04 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (K223154) | Magstim Company, Ltd. | 2023-03-16 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (K222171) | Magstim Company, Ltd. | 2023-01-13 |
| Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K (K220177) | Magnus Medical, Inc. | 2022-09-01 |
| BrainsWay Deep TMS System (K220819) | Brainsway , Ltd. | 2022-08-26 |
| NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health (K222230) | Neuronetics, Inc. | 2022-08-24 |
| NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K220127) | Neuronetics, Inc. | 2022-07-15 |
| ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System (K220625) | Remed Co., Ltd. | 2022-04-06 |
| BTL-995-rTMS (K212723) | BTL Industries, Inc. | 2022-03-04 |
| NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K213543) | Neuronetics, Inc. | 2021-12-10 |
| ALTMS Magnetic Stimulation Therapy System (K202537) | Remed Co., Ltd. | 2021-11-26 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation (K211389) | Magstim Company, Ltd. | 2021-09-14 |
| Deep Transcranial Magnetic Stimulation (DTMS) System (K210201) | Brainsway , Ltd. | 2021-08-17 |
| Brainsway Deep TMS System (K203735) | Brainsway , Ltd. | 2021-04-23 |
| NeuroStar Advanced Therapy (K201158) | Neuronetics, Inc. | 2020-11-20 |
| HORIZON TMS Therapy System with Navigation (K183376) | Magstim Company, Ltd. | 2019-04-03 |
| Nexstim Navigated Brain Therapy (NBT) System 2 (K182700) | Nexstim Plc | 2019-03-22 |
| HORIZON TMS Therapy System (K182853) | Magstim Company, Ltd. | 2019-03-15 |
| Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620) | Tonica Elektronik A/S | 2018-08-14 |
| HORIZON TMS Therapy System (K180907) | Magstim Company, Ltd. | 2018-08-03 |
| Apollo TMS Therapy System (K180313) | Mag & More GmbH | 2018-05-04 |
| Brainsway Deep (DTMS) System (K173540) | Brainsway , Ltd. | 2018-05-03 |
| Neurosoft TMS (also CloudTMS) (K173441) | Teleemg, LLC | 2017-12-13 |
| Nexstim Navigated Brain Therapy (NBT) System 2 (K171902) | Nexstim Plc | 2017-11-10 |
| MagVita TMS Therapy w/MagPro R20 (K172667) | Tonica Elektronik A/S | 2017-10-05 |
| HORIZON Therapy System (K171051) | Magstim Company, Ltd. | 2017-09-13 |
| MagVita TMS Therapy System (K171967) | Tonica Elektronik A/S | 2017-07-25 |
| MagVita TMS Therapy System (K171481) | Tonica Elektronik A/S | 2017-06-16 |
| MagVita TMS Therapy - w/MagPro R20 (K170114) | Tonica Elektronik A/S | 2017-05-01 |
| Rapid2 Therapy System (K162935) | Magstim Company, Ltd. | 2017-03-10 |
| Neurosoft TMS (K160309) | Teleemg, LLC | 2016-12-22 |
| NeuroStar TMS Therapy System (K161519) | Neuronetics, Inc. | 2016-09-11 |
| NeuroStar TMS Therapy System (K160703) | Neuronetics, Inc. | 2016-06-10 |
| MagVita TMS Therapy System (K150641) | Tonica Elektronik A/S | 2015-07-31 |
| Rapid Therapy System (K143531) | Magstim Company Limited | 2015-05-08 |
| NEUROSTAR TMS THERAPY SYSTEM (K133408) | Neuronetics | 2014-03-28 |
| NEUROSTAR TMS THERAPY SYSTEM (K130233) | Neuronetics | 2013-04-30 |
| BRAINSWAY DEEP TMS SYSTEM (K122288) | Brainsway , Ltd. | 2013-01-07 |
| NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 (K083538) | Neuronetics | 2008-12-16 |
| NEUROSTAR TMS SYSTEM (DEN070003) | Neuronetics | 2008-10-07 |