FDA applicant

Brainlab Med. Computersysteme GmbH

85586 Poing/Munchen, DE5 decisions1994–19971 recall

FDA records 5 decisions for Brainlab Med. Computersysteme GmbH (85586 Poing/Munchen, DE) from 1994 to 1997: 5 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and HAW (Neurological Stereotaxic Instrument). 1 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Brainlab Med. Computersysteme GmbH since 2007.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Brainlab Med. Computersysteme GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Brainlab”

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

Brainlab AG 145 Brainlab Medizinische Computersysteme GmbH 1

Brainlab Med. Computersysteme GmbH

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Brainlab”