510(k) Report

FDA applicant

Memtec Corp.

Salem, NH4 decisions1997–20190 recalls

FDA records 4 decisions for Memtec Corp. (Salem, NH) from 1997 to 2019: 4 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 11 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Memtec Corporation”.

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 Memtec Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2010: 12011: 12019: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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