FDA applicant

Galen Robotics

Baltimore, MD1 decision2023–20230 recalls

FDA records 1 decision for Galen Robotics (Baltimore, MD) in 2023: 1 De Novo grant. All are in product code QXG (Cooperative Powered Surgical Assist Device For…). 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, ear, nose and throat panel, where it files most

How often FDA has decided Galen Robotics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Galen Robotics by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Galen Robotics

Which product codes does it file in?

What has FDA decided for it lately?