Data / Medical devices / System, Vocal Cord Medialization / United States
FDA-registered makers of System, Vocal Cord Medialization in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make System, Vocal Cord Medialization (product code MIX). 4 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
- System, Vocal Cord Medialization
- Product code
- MIX
- Country
- United States
Makers of System, Vocal Cord Medialization in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cytophil, Inc | East Troy, WI, United States | Manufacturer | 2 | April 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Boston Medical Products, Inc. | Shrewsbury, MA, United States | Manufacturer | 1 | September 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Merz North America, Inc. | Sturtevant, WI, United States | Manufacturer | 1 | April 18, 2006 | 0 | 0 | 0 | api.fda.gov |
| Merz North America, Inc. | Franksville, WI, United States | Manufacturer | 1 | April 18, 2006 | 0 | 0 | 0 | api.fda.gov |
| Isomedix Operations, Inc. | Libertyville, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uroplasty, LLC | Minnetonka, MN, United States | Manufacturer for export | 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.