510(k) Report

FDA applicant

Anulex Technologies, Inc.

Minnetonka, MN12 decisions2005–20120 recalls

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, last Nov 3, 2026

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

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

FDA decisions per year

3in 2012

2008: 12009: 12010: 12011: 32012: 3
2007high 3 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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.

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