FDA applicant

Bruker Daltonics, Inc.

Bremen, DE3 decisions2013–20250 recalls

FDA records 3 decisions for Bruker Daltonics, Inc. (Bremen, DE) from 2013 to 2025: 3 510(k) clearances. Most are in product codes PEX (System, Mass Spectrometry, Maldi Tof…) and QBN (Mass Spectrometry, Maldi Tof, Microorganism…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bruker Daltonics GmbH & Co. KG”.

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 Bruker Daltonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Bruker Daltonics, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bruker Daltonics, Inc.’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

Other applicant names beginning “Bruker”

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

Bruker Medical Imaging, Inc. 7 Bruker Daltonik GmbH 3

Bruker Daltonics, Inc.

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 “Bruker”