FDA applicant

Spectral Visualization & Development, Inc.

Fredericton,New Brunswick, CA1 decision2004–20040 recalls

FDA records 1 decision for Spectral Visualization & Development, Inc. (Fredericton,New Brunswick, CA) in 2004: 1 510(k) clearance. All are in product code KLW (Masker, Tinnitus). Its devices cite 1 predicate, 0 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, ear, nose and throat panel, where it files most

How often FDA has decided Spectral Visualization & Development, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectral Visualization & Development, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Spectral”

FDA records each applicant name separately; these may or may not be the same firm.

Spectral Diagnostics, Inc. 12 Spectral Data Systems 2 Spectral Medical, Inc. 2

Spectral Visualization & Development, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Spectral”