FDA applicant

Spectrum Designs, Inc.

Goleta, CA18 decisions1994–19993 recalls

FDA records 18 decisions for Spectrum Designs, Inc. (Goleta, CA) from 1994 to 1999: 18 510(k) clearances. Most are in product codes FWP (Prosthesis, Chin, Internal) and LZK (Implant, Malar). 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Spectrum Designs, Inc. since 2007.

Recalls per year

3in 2007

2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Spectrum Designs, 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 “Spectrum”

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

Spectrum Medical, Ltd. 23 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 Spine IP Holdings, LLC 1

Spectrum Designs, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Spectrum”