Data / Medical devices / Helmet, Surgical
Helmet, Surgical (FXZ): 16 FDA-registered makers in 7 countries
16 establishments in 7 countries are registered with the FDA to make Helmet, Surgical (product code FXZ, Class 1, 21 CFR 878.4040). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FXZ
- Device class
- 1
- Regulation
- 878.4040
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 5 |
| India | 1 |
| Mexico | 1 |
| Peru | 1 |
| Austria | 1 |
| Pakistan | 1 |
Makers of Helmet, Surgical
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Hongfeng Co.,ltd | Foshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Aquila Precise Tools Limited | Guangzhou City Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Joinkona Medical Products Stock Co.,ltd | Pingdingshan Henan, China | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Lioncare Protective Products Co., Ltd. | wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & G Seguridad E Higiene Industrial S.A.C. | VENTANILLA Lima(Province), Peru | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thi Total Healthcare Innovation GMBH | Feistritz im Rosental Karnten, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Win Wings Corp. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xianning Full Guard Medical Products Co.,ltd | Xianning City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.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.