Data / Medical devices / Hood, Surgical
Hood, Surgical (FXY): 5 FDA-registered makers in 5 countries
5 establishments in 5 countries are registered with the FDA to make Hood, Surgical (product code FXY, Class 2, 21 CFR 878.4040). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on October 17, 2023, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FXY
- Device class
- 2
- Regulation
- 878.4040
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| Mexico | 1 |
| Austria | 1 |
| Dominican Republic | 1 |
| Turkey | 1 |
Makers of Hood, 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 |
|---|---|---|---|---|---|---|---|---|
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 2 | March 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Stryker Tijuana Operations | Tijuana Baja California, Mexico | Contract manufacturer, Manufacturer | 2 | March 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Thi Total Healthcare Innovation GMBH | Feistritz im Rosental Karnten, Austria | Specification developer | 1 | October 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| AccuMed Corp. | Nigua San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| THI Medikal Sanayi Ticaret A.S | Menderes Izmir, Turkey | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 17, 2023. 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.