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Tonica Elektronik A/S

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
3
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K251125MagVenture TMS Therapy SystemAugust 11, 2025
K251119MagVenture TMS Therapy SystemAugust 8, 2025
K252032T65 (9016E061-)July 30, 2025
K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptAugust 25, 2023
K221544MagVenture TMS Atlas Neuro Navigation SystemMarch 17, 2023
K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemAugust 9, 2020
K173620Mag Vita TMS Therapy System w/Theta Burst StimulationAugust 14, 2018
K172667MagVita TMS Therapy w/MagPro R20October 5, 2017
K171967MagVita TMS Therapy SystemJuly 25, 2017
K171481MagVita TMS Therapy SystemJune 16, 2017
K170114MagVita TMS Therapy - w/MagPro R20May 1, 2017
K162873MEP MonitorMarch 31, 2017
K160280MagPro R20May 16, 2016
K150641MagVita TMS Therapy SystemJuly 31, 2015
K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTIONMarch 26, 2010
K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65July 27, 2007
K061645MAGPRO, MODEL R30October 31, 2006