Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Piezosurgery S.R.L. — 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) |
|---|---|---|---|---|---|
| K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | 2009-12-29 | 245 | 0 |
| K083284 | PIEZOSURGERY MEDICAL | Piezosurgery S.R.L. | 2009-04-08 | 152 | 0 |
| K052518 | PIEZOSURGERY | Piezosurgery S.R.L. | 2005-11-16 | 63 | 0 |
| K043408 | PIEZOSURGERY DEVICE | Piezosurgery S.R.L. | 2005-06-08 | 180 | 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