Data / Medical devices / Set, Tubing, Blood, With And Without Anti-Regurgitation Valve / Mexico
FDA-registered makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve in Mexico: 10 establishments
10 establishments in Mexico are registered with the FDA to make Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Product code
- FJK
- Country
- Mexico
Makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve in Mexico
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 6 | May 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 6 | May 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gambro Renal Products S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 2 | November 3, 2010 | 0 | 0 | 0 | api.fda.gov |
| Baja Fur S.A. de C.V. | Tijuana BC. Baja California, Mexico | Specification developer | 1 | November 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Baja Fur S.A. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 1 | November 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | December 24, 1998 | 0 | 0 | 0 | api.fda.gov |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemotronic De Mexico S De RL | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CV | Tijuana Baja California, 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 |
Updated November 3, 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.