510(k) Report

FDA applicant

Mega Electronics, Ltd.

The Hague, NL4 decisions1997–20150 recalls

FDA records 4 decisions for Mega Electronics, Ltd. (The Hague, NL) from 1997 to 2015: 4 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and HCC (Device, Biofeedback). Its devices cite 11 predicates, 1 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 Mega Electronics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mega Electronics, Ltd.’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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Other applicant names beginning “Mega”

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