FDA applicant
Sterngold/Implamed
FDA records 16 decisions for Sterngold/Implamed (Attleboro, MA) from 1992 to 1999: 16 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and DZE (Implant, Endosseous, Root-Form). Its devices cite 24 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sterngold/Implamed’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sterngold/Implamed since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sterngold/Implamed’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sterngold/Implamed”
FDA records each applicant name separately; these may or may not be the same firm.