ClearanceBrief
Panels › Neurology › Product code OBP · Class 2

Transcranial Magnetic Stimulator

Regulation 882.5805

9510(k)s in 12 months (69 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in OBP

Company510(k)sRecalls
Magstim Company Limited124
Neuronetics132
Tonica Elektronik A/S100
Brainsway , Ltd.80
Mag & More GmbH50
Brain Ultimate, Inc.30
Teleemg, LLC30
BTL Industries, Inc.20
Neuromodulatory Devices & Applications20
Nexstim Plc20
Decided510(k)Device and applicantCode
May 3, 2018K173540Brainsway Deep (DTMS) System
Brainsway , Ltd., IL
OBP
Dec 13, 2017K173441Neurosoft TMS (also CloudTMS)
Teleemg, LLC
OBP
Nov 10, 2017K171902Nexstim Navigated Brain Therapy (NBT) System 2
Nexstim Plc, FI
OBP
Oct 5, 2017K172667MagVita TMS Therapy w/MagPro R20
Tonica Elektronik A/S, DK
OBP
Sep 13, 2017K171051HORIZON Therapy System
Magstim Company, Ltd., GB
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 10, 2017K162935Rapid2 Therapy System
Magstim Company, Ltd., GB
OBP
Dec 22, 2016K160309Neurosoft TMS
Teleemg, LLC
OBP
Sep 11, 2016K161519NeuroStar TMS Therapy System
Neuronetics, Inc.
OBP
Jun 10, 2016K160703NeuroStar TMS Therapy System
Neuronetics, Inc.
OBP
Jul 31, 2015K150641MagVita TMS Therapy System
Tonica Elektronik A/S, DK
OBP
May 8, 2015K143531Rapid Therapy System
Magstim Company Limited, GB
OBP
Mar 28, 2014K133408NEUROSTAR TMS THERAPY SYSTEM
Neuronetics
OBP
Apr 30, 2013K130233NEUROSTAR TMS THERAPY SYSTEM
Neuronetics
OBP
Jan 7, 2013K122288BRAINSWAY DEEP TMS SYSTEM
Brainsway , Ltd., IL
OBP
Dec 16, 2008K083538NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
Neuronetics
OBP
Oct 7, 2008DEN070003NEUROSTAR TMS SYSTEM
Neuronetics
OBP

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