Medical Device Manufacturer · DK , Farum

Tonica Elektronik A/S - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2006

Recent clearances: MagVenture Accelerated TMS (aTMS) Therapy System, MagVenture TMS Therapy System, MagVenture TMS Therapy System

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tonica Elektronik A/S Neurology ✕

17 devices

1-17 of 17

Cleared May 22, 2026

MagVenture Accelerated TMS (aTMS) Therapy System

Neurology · 120d

Cleared Aug 11, 2025

MagVenture TMS Therapy System

Neurology · 122d

Cleared Aug 08, 2025

MagVenture TMS Therapy System

Neurology · 119d

Cleared Jul 30, 2025

T65 (9016E061-)

Neurology · 30d

Cleared Mar 17, 2023

MagVenture TMS Atlas Neuro Navigation System

Neurology · 294d

Cleared Aug 09, 2020

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system

Neurology · 286d

Cleared Aug 14, 2018

Mag Vita TMS Therapy System w/Theta Burst Stimulation

Neurology · 265d

Cleared Oct 05, 2017

MagVita TMS Therapy w/MagPro R20

Neurology · 30d

Cleared Jul 25, 2017

MagVita TMS Therapy System

Neurology · 25d

Cleared Jun 16, 2017

MagVita TMS Therapy System

Neurology · 28d

Cleared May 01, 2017

MagVita TMS Therapy - w/MagPro R20

Neurology · 109d

Cleared Mar 31, 2017

Neurology · 169d

Cleared May 16, 2016

Neurology · 104d

Cleared Jul 31, 2015

MagVita TMS Therapy System

Neurology · 142d

Cleared Mar 26, 2010

MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION

Neurology · 269d

Cleared Jul 27, 2007

COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65

Neurology · 24d

Cleared Oct 31, 2006

MAGPRO, MODEL R30

Neurology · 141d