Data / Medical devices / Set, Administration, Intravascular / Dominican Republic
FDA-registered makers of Set, Administration, Intravascular in the Dominican Republic: 5 establishments
5 establishments in the Dominican Republic are registered with the FDA to make Set, Administration, Intravascular (product code FPA). 3 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
- Set, Administration, Intravascular
- Product code
- FPA
- Country
- Dominican Republic
Makers of Set, Administration, Intravascular in the Dominican Republic
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare, S.A. | Haina San Cristobal, Dominican Republic | Manufacturer | 24 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer, Repackager or relabeler | 2 | June 9, 2011 | 0 | 0 | 0 | api.fda.gov |
| Fenwal International, Inc. | HAINA San Cristobal, Dominican Republic | Manufacturer | 1 | November 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NYPRO DR, LLC (Bldg 11) | Haina San Cristobal, Dominican Republic | 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.