FDA applicant
Anika Therapeutics, Inc.
FDA records 15 decisions for Anika Therapeutics, Inc. (Beford, MA) from 2001 to 2026: 11 510(k) clearances and 4 original PMA approvals. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics…). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 9 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Anika Therapeutics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Anika Therapeutics, 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