510(k) K162516 ยท FMI Needle, Hypodermic, Single Lumen
BD Pen Needle
| Applicant | Becton, Dickinson and Company, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Dec 9, 2016 |
| Received | Sep 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. BD UF PEN 32GX4MM 100 NANO
Item Number: 4292272 Open, Classified |
FMI | None listed |
| Oct 23, 2020 | Becton Dickinson & Company BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector
Catalog Number: 320122 Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.