510(k) K143484 ยท NEU Marker, Radiographic, Implantable
BioZorb Marker
| Applicant | Focal Therapeutics, Portola Valley CA, US |
| Decision | Substantially Equivalent, Jun 29, 2015 |
| Received | Dec 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2024 | Hologic, Inc BioZorb Marker. Radiographic soft tissue marker. Open, Classified |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.