FDA applicant
Hemosonics, LLC
FDA records 8 decisions for Hemosonics, LLC (Durham, NC) from 2019 to 2025: 7 510(k) clearances and 1 De Novo grant. All are in product code QFR (Coagulation System For The Measurement Of…). Its devices cite 9 predicates, 7 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 Hemosonics, LLC’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 2019.
Planning a device like Hemosonics, LLC’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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