Data / Medical devices / United States / Stratus Pharmaceutical
Stratus Pharmaceutical: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
Stratus Pharmaceutical is registered with the FDA (registration 3002787468) in Miami, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002787468
- Address
- 12379 SW 130th Street, Miami, FL, United States, 33186
- Owner or operator
- Stratus Pharmaceuticals Inc. (10061469)
- Roles
- Specification developer
- First device listed
- October 21, 2019
- Registered through
- 2026
- Brand names listed
- Sonafine, Venelex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 19, 2011 | K110172 | SONAFINE WOUND DRESSING | FRO | Substantially Equivalent | Stratus Pharmaceutical | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2011. 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.