FDA applicant

Spectra, Inc.

Wilmington, MA1 decision2009–20090 recalls

FDA records 1 decision for Spectra, Inc. (Wilmington, MA) in 2009: 1 510(k) clearance. All are in product code GDZ (Handle, Scalpel). 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 Spectra, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Spectra, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Spectra”

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

Spectra Medical Devices, Inc. 8 Spectra Science 2 Spectra-Shield, Inc. 1 Spectra-Physics, Inc. 1 Spectra Gases, Inc. 1

Spectra, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Spectra”