FDA applicant

Spectrum Medical Technologies, Inc.

Oviedo, FL3 decisions1992–19970 recalls

FDA records 3 decisions for Spectrum Medical Technologies, Inc. (Oviedo, FL) from 1992 to 1997: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 predicates, 1 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 Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectrum Medical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spectrum Medical 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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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 Diagnostic, Inc. 3 Spectrum Dynamics, Ltd. 3 Spectrum Antimicrobials, Inc. 1 Spectrum Antimicrobials, Inc. (Subsidiary of… 1 Spectrum Spine IP Holdings, LLC 1

Spectrum Medical Technologies, 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 “Spectrum”