Data / Medical devices / United States / SiOxMed, LLC
SiOxMed, LLC: FDA-registered device maker in Winston Salem, NC, United States, 3 510(k) clearances
SiOxMed, LLC is registered with the FDA (registration 3025431504) in Winston Salem, NC, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3025431504
- Address
- 2452 Salem Park Dr, Winston Salem, NC, United States, 27127
- Owner or operator
- SiOxMed (10086784)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 23, 2025
- Registered through
- 2026
- Brand names listed
- SiOxC Cream, SiOxD Wound Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2026 | K250890 | SBC1 Cream | FRO | Substantially Equivalent | Sioxmed, LLC | accessdata.fda.gov |
| March 13, 2025 | K242406 | SiOxC Cream | FRO | Substantially Equivalent | Sioxmed, LLC | accessdata.fda.gov |
| July 5, 2024 | K241660 | SiOxD® Wound Matrix | QSZ | Substantially Equivalent | Sioxmed, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 12, 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.