Data / Medical devices / System, Thermal Regulating / Mexico
FDA-registered makers of System, Thermal Regulating in Mexico: 12 establishments
12 establishments in Mexico are registered with the FDA to make System, Thermal Regulating (product code DWJ). 7 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
- System, Thermal Regulating
- Product code
- DWJ
- Country
- Mexico
Makers of System, Thermal Regulating in Mexico
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 5 | October 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 3 | July 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| SOLVENTUM US LLC (Apodaca) | Apodaca Nuevo Leon, Mexico | Manufacturer | 3 | April 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 2 | October 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| La Ada de Acuna | CIUDAD DE ACUNA Coahuila, Mexico | Manufacturer | 2 | November 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| La Ada De Acuna, S. de. R. L. de C. V. | COL.EDUCATIVA,NOGALES Sonora, Mexico | Manufacturer | 1 | November 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Wear Tex S. De R.L. De C.V. | Torreon Coahuila, Mexico | Exporter to the US, Manufacturer | 1 | July 2, 2010 | 0 | 0 | 0 | api.fda.gov |
| 3M Edumex, S.A De C.V | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, 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.