FDA applicant
Friatec Medical Inc., USA
FDA records 4 decisions for Friatec Medical Inc., USA (Potomac, MD) from 1994 to 1996: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and HRX (Arthroscope). 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 Friatec Medical Inc., USA’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Friatec Medical Inc., USA since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Friatec Medical Inc., USA’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 “Friatec”
FDA records each applicant name separately; these may or may not be the same firm.