FDA applicant
Aziyo Biologics, Inc.
FDA records 4 decisions for Aziyo Biologics, Inc. (Roswell, GA) from 2017 to 2020: 4 510(k) clearances. All are in product code FTM (Mesh, Surgical). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aziyo Biologics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Aziyo Biologics, 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) Report