Magstim Company, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with NavigaOctober 25, 2023
K223154Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimMarch 16, 2023
K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimJanuary 13, 2023
K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with NavigationSeptember 14, 2021
K203684Neurosign V4 Intraoperative Nerve MonitorMarch 17, 2021
K183376HORIZON TMS Therapy System with NavigationApril 3, 2019
K182853HORIZON TMS Therapy SystemMarch 15, 2019
K181559Neurosign V4 Intraoperative Nerve MonitorNovember 9, 2018
K180907HORIZON TMS Therapy SystemAugust 3, 2018
K171051HORIZON Therapy SystemSeptember 13, 2017
K162935Rapid2 Therapy SystemMarch 10, 2017
K130403MAGSTIM DOUBLE 70-2 COILAugust 23, 2013
K083242NEUROSIGN AVALANCHE MOTOR NERVE MONITORJuly 29, 2009
K080499MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00December 8, 2008
K071349NEUROSIGN LARYNGEAL ELECTRODESDecember 12, 2007
K051864MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00December 21, 2005
K053141NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800December 14, 2005
K991583NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITORMay 19, 1999
K980148NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITORAugust 5, 1998
K964869NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITORMay 14, 1997