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Data / Medical devices / Media, Electroconductive

Media, Electroconductive (GYB): 35 FDA-registered makers in 9 countries

35 establishments in 9 countries are registered with the FDA to make Media, Electroconductive (product code GYB, Class 2, 21 CFR 882.1275). 23 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 69 510(k) clearances under this code, the latest on April 8, 2025, and lists 5 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
GYB
Device class
2
Regulation
882.1275
Medical specialty
Neurology

Makers by country

CountryMakers
United States18
China5
Japan4
Germany2
Taiwan2
Italy1
Australia1
Israel1
Canada1

Makers of Media, Electroconductive

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
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer3February 7, 2020000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer3February 7, 2020000api.fda.gov
Parker Laboratories, Inc.Fairfield, NJ, United StatesManufacturer3August 9, 1985020api.fda.gov
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production CenterFukaya-Shi Saitama, JapanManufacturer2February 7, 2020000api.fda.gov
Spes Medica S.P.AGenova Liguria, ItalyExporter to the US, Manufacturer2December 1, 2021000api.fda.gov
BSG CorpActon, MA, United StatesManufacturer1May 14, 1997000api.fda.gov
Cnsac Medshop GMBHTheilheim Bavaria, GermanyManufacturer1June 15, 2022000api.fda.gov
Compumedics LimitedMelbourne Victoria, AustraliaComplaint file establishment, Manufacturer1December 17, 2003000api.fda.gov
Carol Cole Company dba NuFACEVista, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1December 30, 2016000api.fda.gov
D. O. Weaver And CompanyAurora, CO, United StatesManufacturer1September 28, 1988000api.fda.gov
Electro-Cap Intl., Inc.Eaton, OH, United StatesManufacturer1January 5, 2012000api.fda.gov
Endymed Medical LtdCaesarea Northern, IsraelManufacturer1February 7, 2017000api.fda.gov
Guangzhou Xinbo Electronic Co., Ltdguangzhou Guangdong, ChinaManufacturer1November 25, 2020000api.fda.gov
Home Care Technology Co., Ltd.Tainan City, TaiwanExporter to the US, Manufacturer1December 2, 2002000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1June 29, 2000000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer1November 13, 1986000api.fda.gov
Nse Products, Inc.Provo, UT, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1September 13, 2002000api.fda.gov
Prizm Medical, Inc.Buford, GA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1July 30, 2004000api.fda.gov
Shenzhen Ulike Smart Electronics Co.,ltdShenzhen Guangdong, ChinaManufacturer1April 8, 2025000api.fda.gov
Somnomedics AGRANDERSACKER Bavaria, GermanySpecification developer1June 15, 2022000api.fda.gov
Tone-A-Matic International, Inc.MISSISSAUGA Ontario, CanadaManufacturer1September 23, 2022000api.fda.gov
Top-rank Health Care Co.,Ltd.Shaoxing Zhejiang, ChinaContract manufacturer, Manufacturer1December 13, 2022000api.fda.gov
Wuhan Greentek Pty Ltd.Wuhan Hubei, ChinaExporter to the US, Manufacturer1November 8, 2021000api.fda.gov
Amrex-Zetron, Inc.Paramount, CA, United StatesManufacturer0000api.fda.gov
Bear Down Brands, LLCFullerton, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hivox Biotek Inc.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Krenerb, LLCHockessin, DE, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
NORTHWEST COSMETIC LABS, LLC d/b/a Elevation Labs IdahoIdaho Falls, ID, United StatesContract manufacturer0000api.fda.gov
Praywise Technology (dongguan) Co., LtdDongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Silgan Unicep Packaging, LLC.Sandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Silgan Unicep Packaging, LLC.Spokane, WA, United StatesContract manufacturer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer0000api.fda.gov
Wasatch Product Development, LLCDraper, UT, United StatesContract manufacturer0000api.fda.gov

Updated April 8, 2025. 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.