510(k) K213478 ยท FMI Needle, Hypodermic, Single Lumen
BD Pen Needle
| Applicant | Becton, Dickinson and Company, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Jun 28, 2022 |
| Received | Oct 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213478
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | embecta Medical II LLC EWO_02513 (Catalog number 320122)
For Investigational Use Only
Nano Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.