Data / Medical devices / Prosthesis, Nose, Internal / United States
FDA-registered makers of Prosthesis, Nose, Internal in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Prosthesis, Nose, Internal (product code FZE). 6 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
- Prosthesis, Nose, Internal
- Product code
- FZE
- Country
- United States
Makers of Prosthesis, Nose, Internal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Implantech Associates, Inc. | Ventura, CA, United States | Manufacturer | 10 | July 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Hanson Medical, Inc. | Paso Robles, CA, United States | Manufacturer | 2 | June 30, 2010 | 0 | 0 | 0 | api.fda.gov |
| Dsaart, LLC | Carson City, NV, United States | Manufacturer | 1 | July 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| Gyrus Acmi, Inc. | Bartlett, TN, United States | Manufacturer | 1 | September 27, 1978 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | September 27, 1978 | 0 | 0 | 0 | api.fda.gov |
| Surgical Technology Laboratories Inc. | Lugoff, SC, United States | Manufacturer | 1 | November 20, 1998 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | 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.