Data / Medical devices / Eustachian Tube Balloon Dilation Device / United States
FDA-registered makers of Eustachian Tube Balloon Dilation Device in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Eustachian Tube Balloon Dilation Device (product code PNZ). 4 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
- Eustachian Tube Balloon Dilation Device
- Product code
- PNZ
- Country
- United States
Makers of Eustachian Tube Balloon Dilation Device in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 2 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Acclarent, Inc. | Irvine, CA, United States | Specification developer | 1 | February 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fiagon NA LLC | Saint Paul, MN, United States | Manufacturer | 1 | May 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Specification developer | 1 | August 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Interventional Systems | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Corp. | Kalamazoo, MI, United States | 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.