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Data / Medical devices / Stimulator, Auditory, Evoked Response / United States

FDA-registered makers of Stimulator, Auditory, Evoked Response in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Stimulator, Auditory, Evoked Response (product code GWJ). 2 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Stimulator, Auditory, Evoked Response
Product code
GWJ
Country
United States

Makers of Stimulator, Auditory, Evoked Response in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Intelligent Hearing Systems Corp.Miami, FL, United StatesContract manufacturer, Manufacturer7September 29, 2017010api.fda.gov
Diagnostic Group LLCEden Prairie, MN, United StatesComplaint file establishment, Manufacturer, Specification developer3April 24, 2020000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer0000api.fda.gov
Cirtronics CorporationMilford, NH, United StatesContract manufacturer0000api.fda.gov
Ducommun LaBarge TechnologiesAppleton, WI, United StatesContract manufacturer0000api.fda.gov
Firefly Neuroscience, Inc.New York, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Global Interconnect, Inc.Pocasset, MA, United StatesContract manufacturer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Neurofield, Inc.Santa Barbara, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Neuronetrix Solutions, LLCLouisville, KY, United StatesSpecification developer0000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Occam DesignLouisville, KY, United StatesContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Soterix Medical,inc.Woodbridge, NJ, United StatesManufacturer0000api.fda.gov
Universal Brain Inc.Palo Alto, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 2, 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.