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Data / Medical devices / Protector, Hearing (Insert)

Protector, Hearing (Insert) (EWD): 35 FDA-registered makers in 9 countries

35 establishments in 9 countries are registered with the FDA to make Protector, Hearing (Insert) (product code EWD, Class U). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 25, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EWD
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
China13
United States11
Taiwan3
Malaysia2
Hong Kong2
Germany1
Thailand1
India1
Mexico1

Makers of Protector, Hearing (Insert)

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
Alan Safety CompanyTainan, TaiwanContract manufacturer, Exporter to the US0000api.fda.gov
Alan Safety Company- Industrial Park PlantTainan, TaiwanContract manufacturer, Exporter to the US0000api.fda.gov
Ansico (xiamen) Optical Technology Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Changzhou Recoo Healthcare Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Cirrus Healthcare Products LLCEast Dorset, VT, United StatesManufacturer0000api.fda.gov
Cixi Bohong Bath Appliances Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Guangdong J&y Industrial Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangzhou Junyue Foam Earplug Co.,ltd.GUANGZHOU CITY Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hana Microelectronics Public Co.,ltd.A. Muang Lamphun, ThailandContract manufacturer0000api.fda.gov
Hangzhou Greatstar Industrial Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huizhou Gold Rose Technology Co.,ltdhuizhou Guangdong, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Repackager or relabeler0000api.fda.gov
Insta-Mold Products, Inc.Oaks, PA, United StatesManufacturer, Reprocessor, Specification developer0000api.fda.gov
J&y Safety (M) Sdn. Bhd.SHAH ALAM Selangor, MalaysiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Junhe Industry And Trade Co.,ltdYangjiang Guangdong, ChinaManufacturer0000api.fda.gov
Jiangyin Sian Plastic Protech Co., Ltd.Jiangyin Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
K-One MediTech Sdn. BhdIpoh Perak, MalaysiaContract manufacturer0000api.fda.gov
Kaizen Dynamic LimitedHong Kong, Hong KongContract manufacturer0000api.fda.gov
Kobayashi America Manufacturing, LLCDalton, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Mckeon Products, Inc.Warren, MI, United StatesManufacturer0000api.fda.gov
Microsonic, Inc.Ambridge, PA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Ningbo R&m(rato) International Trading Co., Ltd.NINBGO Zhejiang, ChinaManufacturer0000api.fda.gov
Ozone Audio LLCSchaumburg, IL, United StatesSpecification developer0000api.fda.gov
Pro-Optics LLCPalatine, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Samson Innovation Corp. Ltd.Kowloon, Hong KongExporter to the US, Foreign private label distributor, Manufacturer, Specification developer0000api.fda.gov
Scope Medical Devices Private LimitedAmbala City Haryana, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Sperian Hearing Protection de Mexico S.A. de C.V.Tijuana B.C. Mexico, MexicoManufacturer0000api.fda.gov
Unique Safety Equipment Co., Ltd.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Unplugs Hearing IncBrooklyn, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
We Are Dreamers LLCLos Angeles, CA, United StatesSpecification developer0000api.fda.gov
Westone Laboratories, Inc.Colorado Springs, CO, United StatesManufacturer0000api.fda.gov
Wuhan Jinshengyuan Textile Manufacturing Co Ltd.Wuhan Hubei, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Zhejiang Baron Travel Products Co.,ltdJINHUA CITY Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Longmed Medical Technology Co., Ltd.Huzhou Zhejiang, ChinaManufacturer0000api.fda.gov

Updated June 25, 2002. 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.