FDA Product Code
FDA Product Code GWF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1870
510(k) Clearances — 141 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | 2026-09-24 | Special | PDF ↗ |
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | 2026-06-27 | Traditional | PDF ↗ |
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026-01-11 | Traditional | PDF ↗ |
| K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025-01-22 | Special | PDF ↗ |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024-12-12 | Special | PDF ↗ |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024-11-05 | Traditional | PDF ↗ |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024-04-19 | Traditional | PDF ↗ |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | 2024-03-25 | Traditional | PDF ↗ |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023-10-27 | Special | PDF ↗ |
| K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023-08-17 | Traditional | PDF ↗ |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022-03-09 | Traditional | PDF ↗ |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022-01-07 | Traditional | PDF ↗ |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | 2021-08-13 | Traditional | PDF ↗ |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | 2021-05-22 | Traditional | PDF ↗ |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | 2020-10-28 | Traditional | PDF ↗ |
| K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019-02-22 | Traditional | PDF ↗ |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | 2017-04-05 | Special | PDF ↗ |
| K162873 | MEP Monitor | Tonica Elektronik A/S | 2017-03-31 | Traditional | PDF ↗ |
| K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017-03-02 | Traditional | PDF ↗ |
| K160280 | MagPro R20 | Tonica Elektronik A/S | 2016-05-16 | Traditional | PDF ↗ |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | Eb Neuro S.P.A. | 2015-08-19 | Traditional | PDF ↗ |
| K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | 2015-04-24 | Traditional | PDF ↗ |
| K132616 | EPAD | Safeop Surgical, Inc. | 2014-01-24 | Traditional | PDF ↗ |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | The Magstim Company , Ltd. | 2013-08-23 | Special | PDF ↗ |
| K123843 | NEUROEPG SYSTEM | Strohl Medical Technologies | 2013-06-05 | Traditional | PDF ↗ |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | Natus Neurology Incorporated | 2013-05-02 | Special | PDF ↗ |
| K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM | Nihon Kohden Corp. | 2012-09-19 | Traditional | PDF ↗ |
| K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) | Nexstim OY | 2012-05-22 | Traditional | PDF ↗ |
| K120979 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-04-25 | Special | PDF ↗ |
| K112052 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012-03-15 | Traditional | PDF ↗ |
| K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | Inomed Medizintechnik GmbH | 2011-10-06 | Traditional | PDF ↗ |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | Neurovision Medical Products, Inc. | 2011-09-30 | Traditional | PDF ↗ |
| K093304 | PROTEKTOR 32 | Natus Medical, Inc. | 2010-08-11 | Traditional | PDF ↗ |
| K094054 | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE | Nuvasive, Inc. | 2010-05-14 | Special | PDF ↗ |
| K091940 | MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION | Tonica Elektronik A/S | 2010-03-26 | Traditional | PDF ↗ |
| K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM | Nexstim OY | 2009-12-08 | Abbreviated | PDF ↗ |
| K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | Natus Medical, Inc. | 2009-12-08 | Traditional | PDF ↗ |
| K090298 | NUVASIVE NEURO VISION SYSTEM | Nuvasive, Inc. | 2009-06-08 | Traditional | PDF ↗ |
| K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE | Laborie Medical Technologies, Inc. | 2009-03-06 | Traditional | PDF ↗ |
| K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009-02-27 | Traditional | PDF ↗ |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | The Magstim Company , Ltd. | 2008-12-08 | Traditional | PDF ↗ |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | Nihon Kohden America, Inc. | 2008-10-06 | Traditional | PDF ↗ |
| K072343 | NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2007-10-29 | Traditional | PDF ↗ |
| K071821 | COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 | Tonica Elektronik A/S | 2007-07-27 | Special | PDF ↗ |
| K062765 | MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2007-01-24 | Special | PDF ↗ |
| K061639 | ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON | Axon Systems, Inc. | 2006-11-01 | Traditional | PDF ↗ |
| K061645 | MAGPRO, MODEL R30 | Tonica Elektronik A/S | 2006-10-31 | Traditional | PDF ↗ |
| K060847 | MAGSTIM 200-2 | Magstim Company Us, LLC | 2006-09-26 | Traditional | PDF ↗ |
| K061113 | ORTHOMON | Axon Systems, Inc. | 2006-05-23 | Traditional | PDF ↗ |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | The Magstim Company , Ltd. | 2005-12-21 | Traditional | PDF ↗ |
| K051357 | DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH | Digitimer , Ltd. | 2005-09-20 | Traditional | PDF ↗ |
| K051178 | MEE-1000A NEUROMASTER | Nihon Kohden America, Inc. | 2005-08-17 | Traditional | PDF ↗ |
| K050798 | ECLIPSE NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | 2005-08-15 | Traditional | PDF ↗ |
| K051384 | MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | 2005-07-11 | Special | PDF ↗ |
| K030526 | PEDIGUARD NERVE DETECTOR SYSTEM | Spine Vision, Inc. | 2004-12-29 | Traditional | PDF ↗ |
| K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR | Cadwell Laboratories, Inc. | 2004-11-03 | Traditional | PDF ↗ |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | Excel Tech. , Ltd. | 2004-08-06 | Traditional | PDF ↗ |
| K031930 | HIGH SPEED EMG MODULE | Medical Measurement Systems B.V. | 2004-03-03 | Traditional | PDF ↗ |
| K032741 | EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | 2003-12-16 | Traditional | PDF ↗ |
| K020400 | DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR | Meps, LLC | 2002-08-23 | Traditional | PDF ↗ |
| K010092 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-04-02 | Traditional | PDF ↗ |
| K010090 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-03-26 | Traditional | PDF ↗ |
| K010087 | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP | Excel Tech. , Ltd. | 2001-03-19 | Traditional | PDF ↗ |
| K002969 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 | Xltek | 2000-12-08 | Traditional | PDF ↗ |
| K002773 | NEUROMAP WITH NEURO 100 | Radionics, Inc. | 2000-10-23 | Traditional | PDF ↗ |
| K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS | Airsep Corp. | 2000-10-20 | Traditional | PDF ↗ |
| K001101 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 | Excel Tech. , Ltd. | 2000-06-30 | Traditional | PDF ↗ |
| K992911 | MAGSTIM RAPID | Magstim Corporation US | 2000-01-07 | Traditional | PDF ↗ |
| K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES | Nihon Kohden America, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K992313 | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 | Excel Tech. , Ltd. | 1999-08-19 | Traditional | PDF ↗ |
| K981405 | SYNERGY LT | Oxford Instruments, Plc. | 1998-07-16 | Traditional | PDF ↗ |
| K980866 | MEDI-DX 7000 CPT WITH AMREX ELECTRODES | Neuro-Diagnostic Assoc. | 1998-05-20 | Traditional | PDF ↗ |
| K971740 | AMPLAID MK12 | Amplifon S.P.A. | 1998-03-16 | Traditional | PDF ↗ |
| K972959 | AMPLAID MK22 | Amplifon S.P.A. | 1998-02-06 | Traditional | PDF ↗ |
| K971819 | EPOCH 2000 NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | 1997-11-20 | Traditional | PDF ↗ |
| K965065 | TECA. MILLENNIUM | Medelec , Ltd. | 1997-06-20 | Traditional | PDF ↗ |
| K963662 | GALILEO EVOKED POTENTIALRE | Biosound, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K962457 | TWO-CHANNEL PREAMPLIFIER | Cadwell Laboratories, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | Cadwell Laboratories, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | Cadwell Laboratories, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K932994 | EVOKED POTENTIAL SYSTEM-1.0 | Neuromedical Systems, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K960170 | ELECTROENCEPHALOGRAPH (EEG) | Moberg Medical, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K955257 | SS102 DUAL CHANNEL SEP STIMULATOR | Axon Systems, Inc. | 1996-02-02 | Traditional | PDF ↗ |
| K952294 | NEURONET | Computational Diagnostics, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K944547 | DANTEC KEYPOINT | Mckenna & Cuneo | 1995-09-19 | Traditional | PDF ↗ |
| K950208 | NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM | Nihon Kohden America, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | Dantec Medical, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | Dantec Medical, Inc. | 1993-08-31 | Traditional | PDF ↗ |
| K931428 | CADWELL 6200 A | Cadwell Laboratories, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K924723 | CADWELL SIERRA | Cadwell Laboratories, Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K924127 | DANTEC EVOLUTION | Dantec Medical, Inc. | 1993-03-10 | Traditional | PDF ↗ |
| K923303 | SAPPHIRE PREMIERE | Medelec , Ltd. | 1992-11-24 | Traditional | PDF ↗ |
| K923315 | NICOLET ARK SYSTEM | Nicolet Instrument Corp. | 1992-11-23 | Traditional | PDF ↗ |
| K912685 | MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS | Nihon Kohden America, Inc. | 1992-02-26 | Traditional | PDF ↗ |
| K915652 | NICOLET PORATBLE SPIRIT SYSTEM | Nicolet Instrument Corp. | 1992-02-07 | Traditional | PDF ↗ |
| K912775 | SAPPHIRE 4ME EMG/EP SYSTEM | Medelec Intl. Corp. | 1991-11-08 | Traditional | PDF ↗ |
| K905059 | HIGH SPEED MAGNETIC STIMULATOR | Cadwell Laboratories, Inc. | 1991-09-18 | Traditional | PDF ↗ |
| K902607 | DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) | Dantec Medical, Inc. | 1991-05-14 | Traditional | PDF ↗ |
| K903731 | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME | Teca, Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K894560 | QSI 9000 | Quantified Signal Imaging, Inc. | 1990-08-08 | Traditional | PDF ↗ |
Product code GWF · Class II · Neurology. Data: openFDA.