Data / Medical devices / Eustachian Tube Balloon Dilation Device
Eustachian Tube Balloon Dilation Device (PNZ): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Eustachian Tube Balloon Dilation Device (product code PNZ, Class 2, 21 CFR 874.4180). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on February 19, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PNZ
- Device class
- 2
- Regulation
- 874.4180
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Costa Rica | 2 |
| Germany | 1 |
Makers of Eustachian Tube Balloon Dilation Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Spiggle & Theis Medizintechnik GMBH | OVERATH North Rhine-Westphalia, Germany | Specification developer | 1 | August 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Alajuela | Alajuela, Costa Rica | 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 | |
| Nitinol Devices & Components Costa Rica, S. R. L. | El Coyol Alajuela, Costa Rica | 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 February 19, 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.