Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Friatec Medical Inc., USA · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945847 | FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE | Friatec Medical Inc., USA | 1996-03-15 | 471 | 0 |
| K945848 | FRIALIT(R)-2 DENTAL IMPLANT | Friatec Medical Inc., USA | 1996-03-15 | 471 | 0 |
| K945849 | FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING | Friatec Medical Inc., USA | 1996-03-15 | 471 | 0 |
| K934332 | SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES | Friatec Medical Inc., USA | 1994-03-25 | 199 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda