Data / Medical devices / Dressing, Wound, Drug / Mexico
FDA-registered makers of Dressing, Wound, Drug in Mexico: 5 establishments
5 establishments in Mexico are registered with the FDA to make Dressing, Wound, Drug (product code FRO). 1 has a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Dressing, Wound, Drug
- Product code
- FRO
- Country
- Mexico
Makers of Dressing, Wound, Drug in Mexico
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Oculus Technologies of Mexico, S.A de C.V. | Zapopan Jalisco, Mexico | Complaint file establishment, Manufacturer, Specification developer | 13 | June 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| Laboratorios PiSA, S. A. de C.V. | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. De C.V. | Civac Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. de C.V | Jiutepec Morelos, Mexico | Contract 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.