FDA applicant

Spectra Medical Devices, Inc.

Wilmington, MA8 decisions2008–20171 recall

FDA records 8 decisions for Spectra Medical Devices, Inc. (Wilmington, MA) from 2008 to 2017: 8 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and FMF (Syringe, Piston). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Spectra Medical Devices”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Spectra Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008high 1 (2026) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Spectra Medical Devices, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spectra Medical Devices, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Spectra”

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

Spectra Science 2 Spectra-Shield, Inc. 1 Spectra-Physics, Inc. 1 Spectra, Inc. 1 Spectra Gases, Inc. 1

Spectra Medical Devices, 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?

What has been recalled?

Other applicant names beginning “Spectra”