Data / Medical devices / Prosthesis, Tracheal, Expandable / United States
FDA-registered makers of Prosthesis, Tracheal, Expandable in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Prosthesis, Tracheal, Expandable (product code JCT). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Prosthesis, Tracheal, Expandable
- Product code
- JCT
- Country
- United States
Makers of Prosthesis, Tracheal, Expandable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 4 | September 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 2 | July 14, 2023 | 0 | 3 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | July 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Atrium Medical Corporation | Merrimack, NH, United States | Manufacturer | 1 | May 6, 2005 | 0 | 2 | 1 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | December 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxford Performance Materials, Inc. | South Windsor, CT, United States | Complaint file establishment, Contract manufacturer, 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.