Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Chemence Medical Products, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152476 | Exofin High Viscosity Tissue Adhesive | Chemence Medical Products, Inc. | 2016-02-09 | 162 | 0 |
| K101276 | DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 | Chemence Medical Products, Inc. | 2010-07-28 | 83 | 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