FDA applicant
Thi Total Healthcare Innovation GmbH
FDA records 2 decisions for Thi Total Healthcare Innovation GmbH (Feistritz Im Rosental, AT) from 2023 to 2025: 2 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FXY (Hood, Surgical). Its devices cite 2 predicates, 0 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 Thi Total Healthcare Innovation 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 2023.
Planning a device like Thi Total Healthcare Innovation GmbH’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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