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BRAINLAB SE
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (39)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 39
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-10 | 2 | — |
| 2021-05 | 1 | — |
| 2021-06 | 2 | — |
| 2021-07 | 1 | — |
| 2021-10 | 1 | — |
| 2021-11 | 1 | — |
| 2022-06 | 1 | — |
| 2022-09 | 1 | — |
| 2023-02 | 1 | — |
| 2023-05 | 3 | — |
| 2023-10 | 3 | — |
| 2023-11 | 2 | — |
| 2024-03 | 1 | — |
| 2024-04 | 1 | — |
| 2024-05 | 1 | — |
| 2024-07 | 1 | — |
| 2024-09 | 1 | — |
| 2024-10 | 1 | — |
| 2024-11 | 1 | — |
| 2025-01 | 1 | — |
| 2025-02 | 2 | — |
| 2025-03 | 2 | — |
| 2025-09 | 1 | — |
| 2025-10 | 1 | — |
| 2025-11 | 1 | — |
| 2026-02 | 1 | — |
| 2026-04 | 2 | — |
| 2026-06 | 2 | — |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — BRAINLAB SE
- NAI 2025-02-20 Brainlab SE · 0 citations
- NAI 2025-02-20 Brainlab SE · 0 citations
- NAI 2016-02-25 Brainlab SE · 0 citations
- NAI 2016-02-25 Brainlab SE · 0 citations
- VAI 2013-06-21 Brainlab SE · 3 citations
- VAI 2013-06-21 Brainlab SE · 3 citations
- NAI 2011-05-27 Brainlab SE · 0 citations
- NAI 2011-05-27 Brainlab SE · 0 citations