510(k) K183190 ยท POD Temporary, Internal Use Hemostatic
NuStat
| Applicant | Beeken Biomedical, LLC, Stoughton MA, US |
| Decision | Substantially Equivalent, Sep 25, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2021 | Beeken Biomedical, LLC NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding
REF: XR-0812-5 Open, Classified |
POD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.