FDA applicant

Northeast Scientific, Inc. (Nes)

Waterbury, CT1 decision2018–20180 recalls

FDA records 1 decision for Northeast Scientific, Inc. (Nes) (Waterbury, CT) in 2018: 1 510(k) clearance. All are in product code NUJ (Electrosurgical, Cutting & Coagulation…). Its devices cite 1 predicate, 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 Northeast Scientific, Inc. (Nes)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Northeast Scientific, Inc. (Nes) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Northeast Scientific, Inc. (Nes)’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 “Northeast”

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

Northeast Biomedical Labs., Inc. 9 Northeast Scientific, Inc. 6 Northeast Orthotics and Prothetics, Inc. 1 Northeast Iowa Podiatry 1 Northeast Resins & Silicones, LLC 1

Northeast Scientific, Inc. (Nes)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Northeast”