FDA applicant

Spectrum International

Pleasant Hill, CA1 decision2006–20060 recalls

FDA records 1 decision for Spectrum International (Pleasant Hill, CA) in 2006: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 3 predicates, 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, general and plastic surgery panel, where it files most

How often FDA has decided Spectrum International’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectrum International since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Spectrum”

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

Spectrum Medical, Ltd. 23 Spectrum Designs, Inc. 18 Spectrum X-Ray Corp. 9 Spectrum Dynamics Medical, Ltd. 8 Spectrum Spine, LLC 8 Spectrum Vascular 6 Spectrum Co. 3 Spectrum Medical Technologies, Inc. 3 Spectrum Diagnostic, Inc. 3 Spectrum Dynamics, Ltd. 3 Spectrum Antimicrobials, Inc. 1 Spectrum Antimicrobials, Inc. (Subsidiary of… 1

Spectrum International

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 “Spectrum”