510(k) Report

FDA applicant

Chemence Medical, Inc.

Alpharetta, GA6 decisions2006–20210 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Chemence Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12017: 12020: 22021: 1
2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chemence Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Chemence”

FDA records each applicant name separately; these may or may not be the same firm.