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Data / Medical devices / Helmet, Surgical / China

FDA-registered makers of Helmet, Surgical in China: 6 establishments

6 establishments in China are registered with the FDA to make Helmet, Surgical (product code FXZ). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Helmet, Surgical
Product code
FXZ
Country
China

Makers of Helmet, Surgical in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Foshan Hongfeng Co.,ltdFoshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangzhou Aquila Precise Tools LimitedGuangzhou City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Henan Joinkona Medical Products Stock Co.,ltdPingdingshan Henan, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
Hubei Lioncare Protective Products Co., Ltd.wuhan Hubei, ChinaManufacturer0000api.fda.gov
Xianning Full Guard Medical Products Co.,ltdXianning City Hubei, ChinaManufacturer0000api.fda.gov
Xiantao Daoqi Plastic Co., Ltd.Xiantao Hubei, ChinaContract manufacturer, 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.