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Panels › Neurology › Product code GWF · Class 2

Stimulator, Electrical, Evoked Response

Regulation 882.1870

3510(k)s in 12 months (141 all time)
2recalls in 12 months (17 all time)
17recalls that name a 510(k)
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Top companies in GWF

Company510(k)sRecalls
Cadwell Laboratories, Inc.120
Medtronic Xomed, Inc.27
Nihon Kohden America, Inc.72
Axon Systems, Inc.70
Excel Tech. , Ltd.60
Tracor Northern, Inc.60
Cadwell Industries, Inc.23
Dantec Medical, Inc.50
Nuvasive, Inc.50
Tonica Elektronik A/S50
Decided510(k)Device and applicantCode
Sep 24, 2026K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
inomed Medizintechnik GmbH, DE
GWF
Jun 27, 2026K253301BraiN20® (BraiN20)
Time IS Brain, S.L., ES
GWF
Jan 11, 2026K252842SafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
GWF
Jan 22, 2025K243982Nicolet EDX
Natus Neurology Incorporated
GWF
Dec 12, 2024K243495Natus Ultrapro S100 (982A0594)
Natus Neurology Incorporated
GWF
Nov 5, 2024K242345Delphi Stimulator
Quantalx Neuroscience, IL
GWF
Apr 19, 2024K234092SafeOp 3: Neural Informatix Systeem
Alphatec Spine, Inc.
GWF
Mar 25, 2024K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
Soterix Medical, Inc.
GWF
Oct 27, 2023K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Inomed Medizintechnik GmbH, DE
GWF
Aug 17, 2023K230415Cadwell Guardian
Cadwell Industries, Inc.
GWF
Mar 9, 2022K213849SafeOp 2: Neural Informatix System
Alphatec Spine, Inc.
GWF
Jan 7, 2022K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Inomed Medizintechnik GmbH, DE
GWF
Aug 13, 2021K192823MEGA-TMS
Soterix Medical, Inc.
GWF
May 22, 2021K190703Neuro-IOM system with Neuro-IOM.NET software
Neurosoft , Ltd., RU
GWF
Oct 28, 2020K200759NIM Vital, Nerve Integrity Monitor
Medtronic Xomed, Inc.
GWF
Feb 22, 2019K182542The EPAD 2 System
Safeop Surgical, Inc.
GWF
Apr 5, 2017K170677Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
Neurovision Medical Product, Inc.
GWF
Mar 31, 2017K162873MEP Monitor
Tonica Elektronik A/S, DK
GWF
Mar 2, 2017K162199Cascade IOMAX Intraoperative Monitor
Cadwell Industries, Inc.
GWF
May 16, 2016K160280MagPro R20
Tonica Elektronik A/S, DK
GWF
Aug 19, 2015K150220STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
Eb Neuro S.P.A., IT
GWF
Apr 24, 2015K142624Neuromaster G1 MEE200
Nihon Kohden Corporation, JP
GWF
Jan 24, 2014K132616EPAD
Safeop Surgical, Inc.
GWF
Aug 23, 2013K130403MAGSTIM DOUBLE 70-2 COIL
The Magstim Company , Ltd.
GWF
Jun 5, 2013K123843NEUROEPG SYSTEM
Strohl Medical Technologies
GWF
May 2, 2013K130346SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
Natus Neurology Incorporated
GWF
Sep 19, 2012K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
Nihon Kohden Corp.
GWF
May 22, 2012K112881NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
Nexstim OY, FI
GWF
Apr 25, 2012K120979CAREFUSION NICOLET EDX
Carefusion 209, Inc.
GWF
Mar 15, 2012K112052CAREFUSION NICOLET EDX
Carefusion 209, Inc.
GWF
Oct 6, 2011K111647C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
Inomed Medizintechnik GmbH, DE
GWF
Sep 30, 2011K110140NEUROVISION NERVE LOCATOR MONITOR
Neurovision Medical Products, Inc.
GWF
Aug 11, 2010K093304PROTEKTOR 32
Natus Medical, Inc., CA
GWF
May 14, 2010K094054MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
Nuvasive, Inc.
GWF
Mar 26, 2010K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
Tonica Elektronik A/S, DK
GWF
Dec 8, 2009K091457NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
Nexstim OY
GWF
Dec 8, 2009K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
Natus Medical, Inc.
GWF
Jun 8, 2009K090298NUVASIVE NEURO VISION SYSTEM
Nuvasive, Inc.
GWF
Mar 6, 2009K082614EVOX ELECTRO DIAGNOSTIC DEVICE
Laborie Medical Technologies, Inc.
GWF
Feb 27, 2009K083124NIM 3.0
Medtronic Xomed, Inc.
GWF
Dec 8, 2008K080499MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
The Magstim Company , Ltd., GB
GWF
Oct 6, 2008K071969SEN-4100 ELECTRIC STIMULATOR
Nihon Kohden America, Inc.
GWF
Oct 29, 2007K072343NEUROVISION JJB SYSTEM
Nuvasive, Inc.
GWF
Jul 27, 2007K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
Tonica Elektronik A/S, DK
GWF
Jan 24, 2007K062765MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
Nuvasive, Inc.
GWF
Nov 1, 2006K061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
Axon Systems, Inc.
GWF
Oct 31, 2006K061645MAGPRO, MODEL R30
Tonica Elektronik A/S, DK
GWF
Sep 26, 2006K060847MAGSTIM 200-2
Magstim Company Us, LLC
GWF
May 23, 2006K061113ORTHOMON
Axon Systems, Inc.
GWF
Dec 21, 2005K051864MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
The Magstim Company , Ltd., GB
GWF

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