Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vydence Medical Industria E Comercio Ltda · 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) |
|---|---|---|---|---|---|
| K220041 | HandPICO | Vydence Medical Industria E Comercio Ltda | 2022-05-05 | 120 | 0 |
| K202998 | Vydence Zye and Vydence One | Vydence Medical Industria E Comercio Ltda | 2021-10-26 | 390 | 0 |
| K190007 | Vydence Laser Family | Vydence Medical Industria E Comercio Ltda | 2019-03-01 | 58 | 0 |
| K171443 | Etherea MX | Vydence Medical Industria E Comercio Ltda | 2018-04-20 | 339 | 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