FDA applicant
Chemence Medical, Inc.
FDA records 6 decisions for Chemence Medical, Inc. (Alpharetta, GA) from 2006 to 2021: 6 510(k) clearances. Most are in product codes MPN (Tissue Adhesive For The Topical Approximation…) and OMD (Cutaneous Tissue Adhesive With Mesh). Its devices cite 8 predicates, 2 of them its own earlier devices. 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 Chemence Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Chemence Medical, Inc.’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 “Chemence”
FDA records each applicant name separately; these may or may not be the same firm.