FDA applicant
Memtec Corp.
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
How often FDA has decided Memtec Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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.
See the 510(k) Report