FDA applicant

Aktormed GmbH

Neutraubling, DE5 decisions2018–20260 recalls

FDA records 5 decisions for Aktormed GmbH (Neutraubling, DE) from 2018 to 2026: 5 510(k) clearances. Most are in product codes NAY (System, Surgical, Computer Controlled Instrument) and QZB (Software Controlled Endoscope And Instrument…). Its devices cite 5 predicates, 3 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2024

2018high 2 (2024) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Aktormed GmbH by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aktormed GmbH’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

Aktormed GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?