FDA applicant
Anulex Technologies, Inc.
FDA records 12 decisions for Anulex Technologies, Inc. (Minnetonka, MN) from 2005 to 2012: 12 510(k) clearances. Most are in product codes GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) and GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). Its devices cite 22 predicates, 11 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 Anulex Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Anulex Technologies, 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