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Data / Medical devices / Stimulator, Electrical, Evoked Response

Stimulator, Electrical, Evoked Response (GWF): 73 FDA-registered makers in 17 countries

73 establishments in 17 countries are registered with the FDA to make Stimulator, Electrical, Evoked Response (product code GWF, Class 2, 21 CFR 882.1870). 27 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 141 510(k) clearances under this code, the latest on September 24, 2026, and lists 13 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
GWF
Device class
2
Regulation
882.1870
Medical specialty
Neurology

Makers by country

CountryMakers
United States47
Japan4
Germany3
China3
Denmark2
United Kingdom2
Netherlands2
Russia1
Finland1
Italy1
Canada1
Ireland1
Israel1
Costa Rica1
Australia1
Dominican Republic1
Poland1

Makers of Stimulator, Electrical, Evoked Response

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer, Specification developer6January 22, 2025000api.fda.gov
Tonica Elektronik A/SFARUM Hovedstaden, DenmarkContract manufacturer, Manufacturer6March 31, 2017000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer5October 28, 2020041api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer4January 11, 2026010api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer4January 11, 2026000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer4May 14, 2010000api.fda.gov
Inomed Medizintechnik GMBHEMMENDINGEN Baden-Wurttemberg, GermanyManufacturer4September 24, 2026000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer4April 24, 2015020api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer4April 24, 2015000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer4April 24, 2015000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesManufacturer4May 14, 2010000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer4April 24, 2015000api.fda.gov
Nihon Kohden Tomioka CorporationGunma Tokyo, JapanManufacturer4April 24, 2015000api.fda.gov
The Magstim Company Ltd.Carmarthenshire Wales, United KingdomComplaint file establishment, Manufacturer4August 23, 2013000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer, Specification developer2August 17, 2023030api.fda.gov
Digitimer Ltd.Welwyn Garden City Hertfordshire, United KingdomManufacturer2September 20, 2005000api.fda.gov
Neurosoft LtdIvanovo Ivanovskaya Oblast', RussiaManufacturer2August 13, 2021000api.fda.gov
Nexstim PlcHelsinki Uusimaa, FinlandManufacturer2May 22, 2012010api.fda.gov
Soterix Medical,inc.Woodbridge, NJ, United StatesManufacturer2March 25, 2024000api.fda.gov
Computational Diagnostics, Inc.Oakland, PA, United StatesManufacturer, Repackager or relabeler, Specification developer1January 26, 1996000api.fda.gov
Eb Neuro S.P.A.Arbizzano di Valpolicella Verona, ItalyManufacturer1August 19, 2015000api.fda.gov
Laborie Medical Technologies Corp.Portsmouth, NH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1March 3, 2004000api.fda.gov
LKC Technologies, Inc.Germantown, MD, United StatesManufacturer1March 4, 1982000api.fda.gov
Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek)OAKVILLE Ontario, CanadaComplaint file establishment, Specification developer1August 11, 2010010api.fda.gov
Neurovision Medical Products, Inc.Ventura, CA, United StatesManufacturer1April 5, 2017000api.fda.gov
Natus Manufacturing LimitedGORT, Co. Galway(County), IrelandContract manufacturer, Manufacturer1December 12, 2024000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer1August 17, 2005000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Ad-Tech Medical Instrument Corp.Oak Creek, WI, United StatesManufacturer0000api.fda.gov
Alpha Omega Engineering Ltd.Nof HaGalil Northern, IsraelComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
ATL Technology CR LimitadaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Brain Science Tools BVDe Bilt Utrecht, NetherlandsComplaint file establishment, Manufacturer0000api.fda.gov
Cirtec MedicalBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Compumedics LimitedMelbourne Victoria, AustraliaComplaint file establishment, Manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Demcon Production B.V.Enschede Overijssel, NetherlandsContract manufacturer0000api.fda.gov
Ducommun LaBarge TechnologiesAppleton, WI, United StatesContract manufacturer0000api.fda.gov
Eemagine Medical Imaging Solutions GMBHBerlin, GermanyManufacturer0000api.fda.gov
Exxelia MicropenHoneoye Falls, NY, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Fideltronik Poland SP. Z O.O.Sucha Beskidzka Malopolskie, PolandContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Intelligent Hearing Systems Corp.Miami, FL, United StatesManufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Magnus Medical Inc.Burlingame, CA, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer0000api.fda.gov
Onyx Healthcare Usa, Inc.Orange, CA, United StatesManufacturer0000api.fda.gov
Paul E. Danchell A/SJyderup Sjaelland, DenmarkContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Shandong Weigao Orthopaedic Device Co.,ltdweihai Shandong, ChinaContract manufacturer0000api.fda.gov
Shenzhen Launch Electrical Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Xian Friendship Medical Electronics Co., Ltd.Xi'an Shaanxi, ChinaContract manufacturer0000api.fda.gov

Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.