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Data / Medical devices / Full-Montage Standard Electroencephalograph

Full-Montage Standard Electroencephalograph (GWQ): 77 FDA-registered makers in 22 countries

77 establishments in 22 countries are registered with the FDA to make Full-Montage Standard Electroencephalograph (product code GWQ, Class 2, 21 CFR 882.1400). 30 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 189 510(k) clearances under this code, the latest on June 13, 2026, and lists 21 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
GWQ
Device class
2
Regulation
882.1400
Medical specialty
Neurology

Makers by country

CountryMakers
United States35
Japan5
Germany5
United Kingdom4
Canada3
China3
Mexico3
South Korea2
Italy2
Austria2
Poland2
Australia1
Hungary1
Finland1
Bulgaria1
Spain1
Israel1
Iceland1
Malaysia1
Russia1
Taiwan1
India1

Makers of Full-Montage Standard Electroencephalograph

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 Medical Incorporated Dba Excel-Tech Ltd. (xltek)OAKVILLE Ontario, CanadaComplaint file establishment, Manufacturer, Specification developer9June 14, 2018030api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer4September 1, 2018000api.fda.gov
Compumedics LimitedMelbourne Victoria, AustraliaComplaint file establishment, Exporter to the US, Manufacturer4February 9, 2023000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer4August 25, 2017010api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer4August 25, 2017000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer4August 25, 2017000api.fda.gov
Neurovirtual Usa, Inc.Fort Lauderdale, FL, United StatesManufacturer3April 24, 2020000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer3November 6, 2006060api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer3August 25, 2017000api.fda.gov
Zeto EU Kft.Szeged, HungaryManufacturer, Repackager or relabeler3March 13, 2026000api.fda.gov
BSG CorpActon, MA, United StatesManufacturer2June 19, 2012000api.fda.gov
Blackrock MicrosystemsSalt Lake City, UT, United StatesManufacturer, Specification developer2May 2, 2013000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer2October 15, 2001010api.fda.gov
Advanced Brain Monitoring, Inc.Carlsbad, CA, United StatesManufacturer1November 27, 2013000api.fda.gov
Ambulatory Monitoring, Inc.Ardsley, NY, United StatesRepackager or relabeler, Specification developer1June 25, 1986000api.fda.gov
Bee Medic GMBHBamberg Bavaria, GermanyManufacturer1December 30, 2020000api.fda.gov
Brainmaster Technologies, Inc.Bedford, OH, United StatesManufacturer1January 26, 2016000api.fda.gov
Cumulus NeuroscienceBelfast Antrim and Newtownabbey, United KingdomComplaint file establishment, Manufacturer1April 27, 2023000api.fda.gov
Eemagine Medical Imaging Solutions GMBHBerlin, GermanyManufacturer1September 12, 2005000api.fda.gov
Firefly Neuroscience, Inc.New York, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1December 13, 2017000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer1July 19, 2011000api.fda.gov
Imedisync Inc.Gangnam-gu Seoul, South KoreaManufacturer1August 10, 2022000api.fda.gov
Lifelines Ltd.WOKING Surrey, United KingdomSpecification developer1May 4, 2018000api.fda.gov
Medeia Group LtdSofia Sofia-Grad, BulgariaManufacturer1March 17, 2020000api.fda.gov
Neuroelectrics Barcelona S.L.U.Barcelona Catalonia, SpainComplaint file establishment, Exporter to the US, Manufacturer1June 13, 2026000api.fda.gov
Neurofield, Inc.Santa Barbara, CA, United StatesComplaint file establishment, Manufacturer1August 31, 2023000api.fda.gov
Nihon Kohden Tomioka CorporationGunma Tokyo, JapanManufacturer1July 29, 2011000api.fda.gov
Spark Neuro, Inc.New York, NY, United StatesManufacturer1August 18, 2023000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer1March 2, 1994000api.fda.gov
Wavi CoDenver, CO, United StatesManufacturer1May 6, 2022010api.fda.gov
Alpha Omega Engineering Ltd.Nof HaGalil Northern, IsraelComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Burke L. Mays And Associates, Inc.Franklin, TN, United StatesManufacturer0000api.fda.gov
Beacon Biosignals - Cleveland SiteCleveland, OH, United StatesSpecification developer0000api.fda.gov
Ceribell, Inc.Sunnyvale, CA, United StatesManufacturer0000api.fda.gov
Chemigraphic LtdCrawley West Sussex, United KingdomContract manufacturer0000api.fda.gov
Cirtronics CorporationMilford, NH, United StatesContract manufacturer0000api.fda.gov
Co-Ax Technology, Inc.Solon, OH, United StatesContract manufacturer0000api.fda.gov
Controltek, Inc.Vancouver, WA, United StatesContract manufacturer0000api.fda.gov
Ducommun LaBarge TechnologiesAppleton, WI, United StatesContract manufacturer0000api.fda.gov
Eb Neuro S.P.A.Arbizzano di Valpolicella Verona, ItalyManufacturer0000api.fda.gov
Eb Neuro, S.P.A.FLORENCE Tuscany, ItalyContract manufacturer, Manufacturer0000api.fda.gov
Ems Handels Gesellschaft M.B.H.Korneuburg Niederosterreich, AustriaManufacturer0000api.fda.gov
Epm Global Services Inc., Dba VexosMarkham Ontario, CanadaContract manufacturer0000api.fda.gov
Fideltronik Poland SP. Z O.O.Sucha Beskidzka Malopolskie, PolandContract manufacturer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Inomed Medizintechnik GMBHEMMENDINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Kvikna Medical ehfReykjavik, IcelandSpecification developer0000api.fda.gov
Leonhard Lang GMBHINNSBRUCK Tirol, AustriaContract manufacturer0000api.fda.gov
Lidco Ltd.LONDON England, United KingdomManufacturer0000api.fda.gov
Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)GANANOQUE Ontario, CanadaContract manufacturer0000api.fda.gov
Magstim IncEugene, OR, United StatesManufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHDPasir Gudang Johor, MalaysiaComplaint file establishment, Manufacturer0000api.fda.gov
Neurosoft LtdIvanovo Ivanovskaya Oblast', RussiaManufacturer0000api.fda.gov
Neurotronics, LLCAlachua, FL, United StatesManufacturer0000api.fda.gov
Nicolay GMBHNAGOLD Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer0000api.fda.gov
Nihon Vinyl Cord Corporation - Kodama Second FactoryHonjo-shi Saitama, JapanContract manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Universal Brain Inc.Palo Alto, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov
Xian Friendship Medical Electronics Co., Ltd.Xi'an Shaanxi, ChinaContract manufacturer0000api.fda.gov
Ybrain Inc.Daejeon, South KoreaContract manufacturer0000api.fda.gov

Updated June 13, 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.