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Data / Medical devices / Electrode, Cutaneous / United States

FDA-registered makers of Electrode, Cutaneous in the United States: 77 establishments

77 establishments in the United States are registered with the FDA to make Electrode, Cutaneous (product code GXY). 53 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Electrode, Cutaneous
Product code
GXY
Country
United States

Makers of Electrode, Cutaneous in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cardinal HealthHazelwood, MO, United StatesSpecification developer9April 21, 2009000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer8June 28, 2018000api.fda.gov
Ceribell, Inc.Sunnyvale, CA, United StatesManufacturer7April 3, 2026000api.fda.gov
Rhythmlink International, LLCColumbia, SC, United StatesManufacturer, Repackager or relabeler, Specification developer7February 9, 2021000api.fda.gov
BSG CorpActon, MA, United StatesManufacturer6January 29, 2010000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer, Specification developer6December 29, 1994000api.fda.gov
Cardinal HealthWabasha, MN, United StatesContract manufacturer, Manufacturer6April 21, 2009010api.fda.gov
The Electrode StoreBuckley, WA, United StatesManufacturer, Manufacturer for export4August 14, 2009000api.fda.gov
Axelgaard MFG. Co., Ltd.Fallbrook, CA, United StatesManufacturer3February 13, 2014000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer3June 1, 2020000api.fda.gov
Infinite Biomedical Technologies, LLCBaltimore, MD, United StatesManufacturer3April 15, 2024000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer3October 30, 2016000api.fda.gov
Axiobionics, LLC, Center for NeuroprostheticsAnn Arbor, MI, United StatesManufacturer, Remanufacturer, Repackager or relabeler2November 14, 2014010api.fda.gov
Bear Down Brands, LLCFullerton, CA, United StatesComplaint file establishment, Specification developer2July 25, 2014000api.fda.gov
Coapt LLCChicago, IL, United StatesComplaint file establishment, Manufacturer, Remanufacturer2December 30, 2022020api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer2June 1, 2020000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2October 23, 2009010api.fda.gov
Dymedix Diagnostics IncShoreview, MN, United StatesSpecification developer2January 21, 2020000api.fda.gov
Electro-Cap Intl., Inc.Eaton, OH, United StatesManufacturer, Repackager or relabeler2January 27, 2012000api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesContract manufacturer, Manufacturer2March 3, 2003000api.fda.gov
InterX TechnologiesPlano, TX, United StatesManufacturer, Repackager or relabeler2June 21, 2013000api.fda.gov
LifeSync CorporationCoral Springs, FL, United StatesComplaint file establishment, Specification developer2June 3, 2015000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer, Specification developer2December 19, 2006000api.fda.gov
Prizm Medical, Inc.Buford, GA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer2February 21, 1995000api.fda.gov
Somatics, LLCVenice, FL, United StatesComplaint file establishment, Specification developer2March 14, 1989000api.fda.gov
Accelerated Care Plus Corp.Reno, NV, United StatesSpecification developer1May 23, 2001000api.fda.gov
Ampcare, LLCFort Worth, TX, United StatesManufacturer1October 15, 2012000api.fda.gov
Biowave CorporationNorwalk, CT, United StatesManufacturer, Specification developer1July 8, 2021000api.fda.gov
Clearlake-Tech IncClear Lake, SD, United StatesManufacturer1January 3, 2023000api.fda.gov
Columbia Scientific Development, LLCPortland, OR, United StatesSpecification developer1May 30, 2008000api.fda.gov
Eagle Electrode Manufacturing, LLCIjamsville, MD, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1June 11, 2003000api.fda.gov
Everyway4allChino, CA, United StatesSpecification developer1August 3, 2009000api.fda.gov
Electrostim Medical Services, Inc.Tampa, FL, United StatesSpecification developer1December 4, 2009000api.fda.gov
Fashionable, Inc.Largo, FL, United StatesComplaint file establishment, Specification developer1November 22, 2013000api.fda.gov
FISHER WALLACE LABORATORIES IncBrooklyn, NY, United StatesSpecification developer1January 30, 1992000api.fda.gov
Gereonics, Inc.Irvine, CA, United StatesSpecification developer1January 12, 2005000api.fda.gov
Hugh Steeper Ltd DBA SteeperUSAHopkinton, MA, United StatesRemanufacturer1November 29, 2018000api.fda.gov
Imex, LLCFulton, MD, United StatesManufacturer1January 24, 2014000api.fda.gov
Inspirstar, Inc.Chandler, AZ, United StatesSpecification developer1May 31, 2006000api.fda.gov
Intelligent Hearing Systems Corp.Miami, FL, United StatesManufacturer1December 11, 2006000api.fda.gov
Ives EEG SolutionsNewburyport, MA, United StatesManufacturer1September 7, 2007000api.fda.gov
Krenerb, LLCHockessin, DE, United StatesRepackager or relabeler, Specification developer1July 25, 2014000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer1January 19, 2023000api.fda.gov
Motive Health, Inc.Tempe, AZ, United StatesManufacturer1March 22, 2023000api.fda.gov
Neurometrix, Inc.Rockaway, NJ, United StatesManufacturer1November 17, 2014000api.fda.gov
Neurotron MedicalWarminster, PA, United StatesManufacturer1December 20, 2005000api.fda.gov
Neurovirtual Usa, Inc.Fort Lauderdale, FL, United StatesManufacturer1April 11, 2017000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesContract manufacturer, Specification developer1April 11, 1985000api.fda.gov
Pepin MFG., Inc.Lake City, MN, United StatesContract manufacturer, Manufacturer1May 23, 2007000api.fda.gov
RS MedicalVancouver, WA, United StatesManufacturer1June 5, 2009010api.fda.gov
Theragen, Inc.Jacksonville, FL, United StatesSpecification developer1January 20, 2012000api.fda.gov
Wavi CoDenver, CO, United StatesManufacturer1April 28, 2017000api.fda.gov
WillowWood Global LLCMt Sterling, OH, United StatesManufacturer1January 11, 2023000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer0000api.fda.gov
AneuvoLos Angeles, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Ascentron, Inc.White City, OR, United StatesContract manufacturer0000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
CGX, LLCSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Dynapulse Medical LLCMinnetonka, MN, United StatesSpecification developer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
EpitelSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Global Interconnect, Inc.Pocasset, MA, United StatesContract manufacturer0000api.fda.gov
Hi Tech Electronic Manufacturing CorporationOceanside, CA, United StatesContract manufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
Jomel Seams Reasonable LLCHillside, NJ, United StatesContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
LEAD-LOK, INC. d.b.a Nissha Medical TechnologiesSandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Morgan Newton CompanyPlano, TX, United StatesContract manufacturer0000api.fda.gov
Neurowave Systems Inc.Beachwood, OH, United StatesManufacturer0000api.fda.gov
Pascall Systems IncCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
R & D Medical Products, Inc.Lake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Svtronics, Inc.Plano, TX, United StatesContract manufacturer0000api.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.