510(k) Report

FDA applicant

Brahms GmbH, Part of Thermo Fisher Scientific

Hennigsdorf, DE1 decision2023–20230 recalls

FDA records 1 decision for Brahms GmbH, Part of Thermo Fisher Scientific (Hennigsdorf, DE) in 2023: 1 De Novo grant. All are in product code QWH (Prognostic Test For Development Or Progression…). 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, clinical chemistry panel, where it files most

How often FDA has decided Brahms GmbH, Part of Thermo Fisher Scientific’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Brahms GmbH, Part of Thermo Fisher Scientific by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Brahms”

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