Data / Medical devices / Balloon Aortic Valvuloplasty / United States
FDA-registered makers of Balloon Aortic Valvuloplasty in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Balloon Aortic Valvuloplasty (product code OZT). 5 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
- Balloon Aortic Valvuloplasty
- Product code
- OZT
- Country
- United States
Makers of Balloon Aortic Valvuloplasty in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 3 | December 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer | 2 | October 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 2 | October 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Numed, Inc. | Hopkinton, NY, United States | Manufacturer | 2 | October 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Intervention Tech, Inc | Flagstaff, AZ, United States | Complaint file establishment, Specification developer | 1 | May 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poba Medical | Flagstaff, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | 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.