Data / Medical devices / Sheet, Burn / United States
FDA-registered makers of Sheet, Burn in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Sheet, Burn (product code FPY). 0 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
- Sheet, Burn
- Product code
- FPY
- Country
- United States
Makers of Sheet, Burn in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GD Group USA Company | Bartlett, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North American Rescue, LLC. | Greer, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OVIK Health | Spartanburg, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safeguard Us Operating, LLC | Huntersville, NC, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterling Medical Products | Prophetstown, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wells Lamont Industrial, LLC | Philadelphia, MS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Water-Jel Technologies, LLC | Huntersville, NC, 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.