Data / Medical devices / Dress, Surgical / United States
FDA-registered makers of Dress, Surgical in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Dress, Surgical (product code FYE). 1 has 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
- Dress, Surgical
- Product code
- FYE
- Country
- United States
Makers of Dress, Surgical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 1 | May 9, 1991 | 0 | 1 | 0 | api.fda.gov |
| American Dawn Inc. | Compton, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anzen Health | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Berkley Medical Resources, Inc. | Smithfield, PA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crosstex International | Rush, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Two One Two New York, Inc. | Edgewood, NY, United States | 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.