510(k) Report

FDA applicant

Surgical Navigation Specialists, Inc.

Mississauga Ontario, CA3 decisions1999–20010 recalls

FDA records 3 decisions for Surgical Navigation Specialists, Inc. (Mississauga Ontario, CA) from 1999 to 2001: 3 510(k) clearances. All are in product code HAW (Neurological Stereotaxic Instrument). 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, neurology panel, where it files most

How often FDA has decided Surgical Navigation Specialists, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgical Navigation Specialists, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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