Data / Medical devices / Shoes, Operating-Room
Shoes, Operating-Room (FXW): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Shoes, Operating-Room (product code FXW, 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 1 510(k) clearance under this code, the latest on January 29, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FXW
- Device class
- 1
- Regulation
- 878.4040
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| Vietnam | 2 |
| Mexico | 1 |
| Paraguay | 1 |
Makers of Shoes, Operating-Room
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 |
|---|---|---|---|---|---|---|---|---|
| Degasa, S.A. De C.V. | Jiutepec Morelos, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Zhongzhi Industry Co.,ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mega Plasticos SA | Minga Guazu Alto Parana, Paraguay | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Samho Co., Ltd | HCMC Ho Chi Minh, Vietnam | Contract 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 Rayxin Medical Products Co., Ltd. | XIANTAO Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 29, 1993. 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.