FDA applicant
Brainlab AG
FDA records 145 decisions for Brainlab AG (Munich, DE) from 1992 to 2026: 145 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 210 predicates, 178 of them its own earlier devices. 46 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Brainlab”, “Brainlab SE”, “Brainlab, Inc.”, “Brainlab , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Brainlab AG’s devices, and how often a recall has named them.
FDA decisions per year
9in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Brainlab AG’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) ReportOther applicant names beginning “Brainlab”
FDA records each applicant name separately; these may or may not be the same firm.