Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list HemoSonics LLC with 7 510(k) clearances. The most recent is a 510(k) clearance dated Aug 25, 2025: Quantra QStat Cartridge.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 25, 2025 | Quantra QStat CartridgeK251404 · QFR | 510(k) clearances |
| Mar 27, 2024 | QStat CartridgeK240045 · QFR | 510(k) clearances |
| Aug 24, 2023 | Quantra Hemostasis AnalyzerK232215 · QFR | 510(k) clearances |
| Mar 24, 2023 | Quantra Hemostasis AnalyzerK230461 · QFR | 510(k) clearances |
| Dec 13, 2022 | Quantra QPlus SystemK223433 · QFR | 510(k) clearances |
| Nov 29, 2022 | QStat CartridgeK213917 · QFR | 510(k) clearances |
| Aug 21, 2020 | Quantra QPlus SystemK201513 · QFR | 510(k) clearances |
| Mar 12, 2019 | Quantra Hemostasis Analyzer, QPlus CartridgeDEN180017 · QFR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
