FDA applicant

Brahms GmbH

Henningsdorf, DE2 decisions2016–20170 recalls

FDA records 2 decisions for Brahms GmbH (Henningsdorf, DE) from 2016 to 2017: 1 510(k) clearance and 1 De Novo grant. Most are in product codes PRI (Procalcitonin Assay) and PMT (Device To Detect And Measure Procalcitonin…). Its devices cite 2 predicates, 1 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2017

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Brahms GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Brahms”

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

Brahms Diagnostica, LLC 6 Brahms Aktiengesellschaft 2 Brahms GmbH, Part of Thermo Fisher Scientific 1 B.R.A.H.M.S GmbH, Part of Thermo Fisher 1

Brahms 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?

Other applicant names beginning “Brahms”