Atlas FDA

GWF

140 FDA 510(k) clearances · Product code

139 daysmedian time to decision
271 days90th percentile
140clearances measured

FDA profile

Official device name
Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 55 · 2022: 45 · 2023: 150 · 2024: 854 · 2025: 1,042 · 2026: 572
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BraiN20® (BraiN20) (K253301)Time IS Brain, S.L.2026-06-27
SafeOp 3: Neural Informatix System (K252842)Alphatec Spine, Inc.2026-01-11
Nicolet EDX (K243982)Natus Neurology Incorporated2025-01-22
Natus Ultrapro S100 (982A0594) (K243495)Natus Neurology Incorporated2024-12-12
Delphi Stimulator (K242345)Quantalx Neuroscience2024-11-05
SafeOp 3: Neural Informatix Systeem (K234092)Alphatec Spine, Inc.2024-04-19
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (K234080)Soterix Medical, Inc.2024-03-25
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K233292)Inomed Medizintechnik GmbH2023-10-27
Cadwell Guardian (K230415)Cadwell Industries, Inc.2023-08-17
SafeOp 2: Neural Informatix System (K213849)Alphatec Spine, Inc.2022-03-09
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K212166)Inomed Medizintechnik GmbH2022-01-07
MEGA-TMS (K192823)Soterix Medical, Inc.2021-08-13
Neuro-IOM system with Neuro-IOM.NET software (K190703)Neurosoft , Ltd.2021-05-22
NIM Vital, Nerve Integrity Monitor (K200759)Medtronic Xomed, Inc.2020-10-28
The EPAD 2 System (K182542)Safeop Surgical, Inc.2019-02-22
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software (K170677)Neurovision Medical Product, Inc.2017-04-05
MEP Monitor (K162873)Tonica Elektronik A/S2017-03-31
Cascade IOMAX Intraoperative Monitor (K162199)Cadwell Industries, Inc.2017-03-02
MagPro R20 (K160280)Tonica Elektronik A/S2016-05-16
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast (K150220)Eb Neuro S.P.A.2015-08-19
Neuromaster G1 MEE200 (K142624)Nihon Kohden Corporation2015-04-24
EPAD (K132616)Safeop Surgical, Inc.2014-01-24
MAGSTIM DOUBLE 70-2 COIL (K130403)The Magstim Company , Ltd.2013-08-23
NEUROEPG SYSTEM (K123843)Strohl Medical Technologies2013-06-05
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION (K130346)Natus Neurology Incorporated2013-05-02
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM (K120397)Nihon Kohden Corp.2012-09-19
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) (K112881)Nexstim OY2012-05-22
CAREFUSION NICOLET EDX (K120979)Carefusion 209, Inc.2012-04-25
CAREFUSION NICOLET EDX (K112052)Carefusion 209, Inc.2012-03-15
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES (K111647)Inomed Medizintechnik GmbH2011-10-06
NEUROVISION NERVE LOCATOR MONITOR (K110140)Neurovision Medical Products, Inc.2011-09-30
PROTEKTOR 32 (K093304)Natus Medical, Inc.2010-08-11
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE (K094054)Nuvasive, Inc.2010-05-14
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION (K091940)Tonica Elektronik A/S2010-03-26
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (K083371)Natus Medical, Inc.2009-12-08
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM (K091457)Nexstim OY2009-12-08
NUVASIVE NEURO VISION SYSTEM (K090298)Nuvasive, Inc.2009-06-08
EVOX ELECTRO DIAGNOSTIC DEVICE (K082614)Laborie Medical Technologies, Inc.2009-03-06
NIM 3.0 (K083124)Medtronic Xomed, Inc.2009-02-27
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 (K080499)The Magstim Company , Ltd.2008-12-08
SEN-4100 ELECTRIC STIMULATOR (K071969)Nihon Kohden America, Inc.2008-10-06
NEUROVISION JJB SYSTEM (K072343)Nuvasive, Inc.2007-10-29
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 (K071821)Tonica Elektronik A/S2007-07-27
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM (K062765)Nuvasive, Inc.2007-01-24
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON (K061639)Axon Systems, Inc.2006-11-01
MAGPRO, MODEL R30 (K061645)Tonica Elektronik A/S2006-10-31
MAGSTIM 200-2 (K060847)Magstim Company Us, LLC2006-09-26
ORTHOMON (K061113)Axon Systems, Inc.2006-05-23
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 (K051864)The Magstim Company , Ltd.2005-12-21
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH (K051357)Digitimer , Ltd.2005-09-20
MEE-1000A NEUROMASTER (K051178)Nihon Kohden America, Inc.2005-08-17
ECLIPSE NEUROLOGICAL WORKSTATION (K050798)Axon Systems, Inc.2005-08-15
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM (K051384)Nuvasive, Inc.2005-07-11
PEDIGUARD NERVE DETECTOR SYSTEM (K030526)Spine Vision, Inc.2004-12-29
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (K042350)Cadwell Laboratories, Inc.2004-11-03
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (K040358)Excel Tech. , Ltd.2004-08-06
HIGH SPEED EMG MODULE (K031930)Medical Measurement Systems B.V.2004-03-03
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION (K032741)Axon Systems, Inc.2003-12-16
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR (K020400)Meps, LLC2002-08-23
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) (K010092)Excel Tech. , Ltd.2001-04-02
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) (K010090)Excel Tech. , Ltd.2001-03-26
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP (K010087)Excel Tech. , Ltd.2001-03-19
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 (K002969)Xltek2000-12-08
NEUROMAP WITH NEURO 100 (K002773)Radionics, Inc.2000-10-23
DA VINCHI EEG AND EMG/EP SYSTEMS (K000963)Airsep Corp.2000-10-20
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 (K001101)Excel Tech. , Ltd.2000-06-30
MAGSTIM RAPID (K992911)Magstim Corporation US2000-01-07
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES (K991899)Nihon Kohden America, Inc.1999-09-01
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 (K992313)Excel Tech. , Ltd.1999-08-19
SYNERGY LT (K981405)Oxford Instruments, Plc.1998-07-16
MEDI-DX 7000 CPT WITH AMREX ELECTRODES (K980866)Neuro-Diagnostic Assoc.1998-05-20
AMPLAID MK12 (K971740)Amplifon S.P.A.1998-03-16
AMPLAID MK22 (K972959)Amplifon S.P.A.1998-02-06
EPOCH 2000 NEUROLOGICAL WORKSTATION (K971819)Axon Systems, Inc.1997-11-20
TECA. MILLENNIUM (K965065)Medelec , Ltd.1997-06-20
GALILEO EVOKED POTENTIALRE (K963662)Biosound, Inc.1997-02-26
TWO-CHANNEL PREAMPLIFIER (K962457)Cadwell Laboratories, Inc.1997-01-13
FOUR-CHANNEL PREAMPLIFIER (K962455)Cadwell Laboratories, Inc.1997-01-13
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (K962458)Cadwell Laboratories, Inc.1997-01-13
EVOKED POTENTIAL SYSTEM-1.0 (K932994)Neuromedical Systems, Inc.1996-04-15
ELECTROENCEPHALOGRAPH (EEG) (K960170)Moberg Medical, Inc.1996-03-01
SS102 DUAL CHANNEL SEP STIMULATOR (K955257)Axon Systems, Inc.1996-02-02
NEURONET (K952294)Computational Diagnostics, Inc.1996-01-26
DANTEC KEYPOINT (K944547)Mckenna & Cuneo1995-09-19
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM (K950208)Nihon Kohden America, Inc.1995-05-10
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) (K931923)Dantec Medical, Inc.1993-11-09
DANTEC MAGNETIC STIMULATOR MAGPRO (K926516)Dantec Medical, Inc.1993-08-31
CADWELL 6200 A (K931428)Cadwell Laboratories, Inc.1993-06-22
CADWELL SIERRA (K924723)Cadwell Laboratories, Inc.1993-03-23
DANTEC EVOLUTION (K924127)Dantec Medical, Inc.1993-03-10
SAPPHIRE PREMIERE (K923303)Medelec , Ltd.1992-11-24
NICOLET ARK SYSTEM (K923315)Nicolet Instrument Corp.1992-11-23
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS (K912685)Nihon Kohden America, Inc.1992-02-26
NICOLET PORATBLE SPIRIT SYSTEM (K915652)Nicolet Instrument Corp.1992-02-07
SAPPHIRE 4ME EMG/EP SYSTEM (K912775)Medelec Intl. Corp.1991-11-08
HIGH SPEED MAGNETIC STIMULATOR (K905059)Cadwell Laboratories, Inc.1991-09-18
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) (K902607)Dantec Medical, Inc.1991-05-14
SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME (K903731)Teca, Inc.1991-02-04
QSI 9000 (K894560)Quantified Signal Imaging, Inc.1990-08-08
SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG (K900482)Axon Systems, Inc.1990-06-20
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