Data / Medical devices / System, Vocal Cord Medialization
System, Vocal Cord Medialization (MIX): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make System, Vocal Cord Medialization (product code MIX, Class 2, 21 CFR 874.3620). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on May 3, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MIX
- Device class
- 2
- Regulation
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of System, Vocal Cord Medialization
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 |
|---|---|---|---|---|---|---|---|---|
| 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 May 3, 2024. 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.