FDA applicant

North East Monitoring, Inc.

Sudbury, MA10 decisions1995–20140 recalls

FDA records 10 decisions for North East Monitoring, Inc. (Sudbury, MA) from 1995 to 2014: 10 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 10 predicates, 7 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, cardiovascular panel, where it files most

How often FDA has decided North East Monitoring, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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North East Monitoring, 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?