Data / Medical devices / United States / Omeza, LLC
Omeza, LLC: FDA-registered device maker in Sarasota, FL, United States, 1 510(k) clearance
Omeza, LLC is registered with the FDA (registration 3019843904) in Sarasota, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019843904
- Address
- 1610 Northgate Blvd, Sarasota, FL, United States, 34234
- Owner or operator
- Omeza, LLC (10082892)
- Roles
- Manufacturer
- First device listed
- October 12, 2021
- Registered through
- 2026
- Brand names listed
- OMEZA Complete Matrix OCM Trademark
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| September 1, 2021 | K211972 | Omeza Collagen Matrix | FRO | Substantially Equivalent | Omeza, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 1, 2021. 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.