ClearanceBrief
Company · DK

Tonica Elektronik A/S

FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.

18510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OBPTranscranial Magnetic Stimulator10
GWFStimulator, Electrical, Evoked Response5
HAWNeurological Stereotaxic Instrument1
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder1
QPLElectromagnetic Stimulator, Pain Relief1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 22, 2026K260189MagVenture Accelerated TMS (aTMS) Therapy System
Tonica Elektronik A/S, DK
OBP
Aug 11, 2025K251125MagVenture TMS Therapy System
Tonica Elektronik A/S, DK
OBP
Aug 8, 2025K251119MagVenture TMS Therapy System
Tonica Elektronik A/S, DK
OBP
Jul 30, 2025K252032T65 (9016E061-)
Tonica Elektronik A/S, DK
OBP
Aug 25, 2023K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Tonica Elektronik A/S, DK
QPL
Mar 17, 2023K221544MagVenture TMS Atlas Neuro Navigation System
Tonica Elektronik A/S, DK
HAW
Aug 9, 2020K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
Tonica Elektronik A/S, DK
QCI
Aug 14, 2018K173620Mag Vita TMS Therapy System w/Theta Burst Stimulation
Tonica Elektronik A/S, DK
OBP
Oct 5, 2017K172667MagVita TMS Therapy w/MagPro R20
Tonica Elektronik A/S, DK
OBP
Jul 25, 2017K171967MagVita TMS Therapy System
Tonica Elektronik A/S, DK
OBP
Jun 16, 2017K171481MagVita TMS Therapy System
Tonica Elektronik A/S, DK
OBP
May 1, 2017K170114MagVita TMS Therapy - w/MagPro R20
Tonica Elektronik A/S, DK
OBP
Mar 31, 2017K162873MEP Monitor
Tonica Elektronik A/S, DK
GWF
May 16, 2016K160280MagPro R20
Tonica Elektronik A/S, DK
GWF
Jul 31, 2015K150641MagVita TMS Therapy System
Tonica Elektronik A/S, DK
OBP
Mar 26, 2010K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
Tonica Elektronik A/S, DK
GWF
Jul 27, 2007K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
Tonica Elektronik A/S, DK
GWF
Oct 31, 2006K061645MAGPRO, MODEL R30
Tonica Elektronik A/S, DK
GWF

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
Get alerts for these product codes