FDA applicant

Aesku Systems GmbH&Co.Kg

Wendelsheim, DE1 decision2016–20160 recalls

FDA records 1 decision for Aesku Systems GmbH&Co.Kg (Wendelsheim, DE) in 2016: 1 510(k) clearance. All are in product code DHN (Antinuclear Antibody, Indirect…). 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, immunology panel, where it files most

How often FDA has decided Aesku Systems GmbH&Co.Kg’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Aesku Systems GmbH&Co.Kg by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Aesku”

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

Aesku Diagnostics 11 Aesku, Inc. 6

Aesku Systems GmbH&Co.Kg

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Aesku”