510(k) K123684 ยท FMI Needle, Hypodermic, Single Lumen
SOL-CARE SAFETY NEEDLE
| Applicant | Sol-Millennium Medical, Lawrenceville GA, US |
| Decision | Substantially Equivalent, May 8, 2013 |
| Received | Nov 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2020 | Cardinal Health 200, LLC Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface Terminated |
FMI | None listed |
| Jan 15, 2020 | Cardinal Health 200, LLC Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.