Data / Medical devices / Tube, Tympanostomy / United States
FDA-registered makers of Tube, Tympanostomy in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Tube, Tympanostomy (product code ETD). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Tube, Tympanostomy
- Product code
- ETD
- Country
- United States
Makers of Tube, Tympanostomy in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 7 | June 19, 2000 | 0 | 0 | 0 | api.fda.gov |
| Grace Medical, Inc. | Memphis, TN, United States | Manufacturer | 6 | November 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gyrus Acmi, Inc. | Bartlett, TN, United States | Manufacturer, Repackager or relabeler | 6 | June 19, 2000 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 5 | July 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Preceptis Medical, Inc | Golden Valley, MN, United States | Manufacturer, Specification developer | 2 | July 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 2 | August 26, 1999 | 0 | 1 | 0 | api.fda.gov |
| Biowy Corporation | Lake Forest, CA, United States | Manufacturer | 1 | February 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Invotec International, Inc. | Jacksonville, FL, United States | Manufacturer | 1 | September 26, 1990 | 0 | 0 | 0 | api.fda.gov |
| Tusker Medical Inc. | Austin, TX, United States | Specification developer | 1 | April 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resolution Medical | Minneapolis, MN, 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.