FDA applicant

Mainstay Medical Limited

Swords, Co Dublin1 decision2020–20200 recalls

FDA records 1 decision for Mainstay Medical Limited (Swords, Co Dublin) in 2020: 1 original PMA approval. All are in product code QLK (Stimulator, Neuromuscular, Lower Back Muscles…). 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, neurology panel, where it files most

How often FDA has decided Mainstay Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Mainstay Medical Limited by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Mainstay Medical Limited

Which product codes does it file in?

What has FDA decided for it lately?