Data / Medical devices / Securement Wound Dressing For Reduction Of Infection
Securement Wound Dressing For Reduction Of Infection (SEL): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Securement Wound Dressing For Reduction Of Infection (product code SEL, Class U). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on July 11, 2017, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SEL
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Securement Wound Dressing For Reduction Of Infection
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 1 | October 26, 2001 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 1 | July 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | July 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 1 | July 11, 2017 | 0 | 0 | 0 | api.fda.gov |
Updated July 11, 2017. 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.