FDA applicant

Brainlab Medizinische Computersysteme GmbH

West Germany, GR1 decision1992–19920 recalls

FDA records 1 decision for Brainlab Medizinische Computersysteme GmbH (West Germany, GR) in 1992: 1 510(k) clearance. All are in product code HAW (Neurological Stereotaxic Instrument). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Brainlab Medizinische Computersysteme GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Brainlab Medizinische Computersysteme…’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 “Brainlab”

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

Brainlab AG 145 Brainlab Med. Computersysteme GmbH 5

Brainlab Medizinische Computersysteme GmbH

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Brainlab”