510(k) Report

FDA applicant

Medtronic Surgical Navigation Technologies

Louisville, CO12 decisions2000–200542 recalls

FDA records 12 decisions for Medtronic Surgical Navigation Technologies (Louisville, CO) from 2000 to 2005: 12 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and DQK (Computer, Diagnostic, Programmable). 42 recalls are 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 Medtronic Surgical Navigation Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Surgical Navigation Technologies since 2007.

Recalls per year

1in 2017

2009: 12010: 52011: 12012: 12014: 252015: 12016: 52017: 1
2007high 25 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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