FDA applicant
Bosch Healthcare Solutions GmbH
FDA records 2 decisions for Bosch Healthcare Solutions GmbH (Waiblingen, DE) from 2024 to 2025: 2 510(k) clearances. All are in product code MXA (System, Test, Breath Nitric Oxide). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bosch Healthcare Solutions GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Bosch Healthcare Solutions GmbH’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 “Bosch”
FDA records each applicant name separately; these may or may not be the same firm.