Data / Medical devices / Silicone Hydrogel For Scar Management / United States
FDA-registered makers of Silicone Hydrogel For Scar Management in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Silicone Hydrogel For Scar Management (product code PFP). 1 has 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
- Silicone Hydrogel For Scar Management
- Product code
- PFP
- Country
- United States
Makers of Silicone Hydrogel For Scar Management in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sonoma Pharmaceuticals, Inc. | Boulder, CO, United States | Manufacturer | 1 | November 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Filltech Usa, LLC | Rockwell, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implus Footcare LLC | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LC Cell | Sarasota, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med Way Inc. | Buford, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediusa Inc. | Los Angeles, CA, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Star Port Inc | Denver, CO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technology Laboratories Inc. | Lugoff, SC, 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.