Hemosonics, LLC

FDA Regulatory Profile

Hemosonics, LLC appears in FDA public data with 0 recalls, 8 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 25, 2025.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251404Quantra QStat CartridgeAugust 25, 2025
K240045QStat CartridgeMarch 27, 2024
K232215Quantra Hemostasis AnalyzerAugust 24, 2023
K230461Quantra Hemostasis AnalyzerMarch 24, 2023
K223433Quantra QPlus SystemDecember 13, 2022
K213917QStat CartridgeNovember 29, 2022
K201513Quantra QPlus SystemAugust 21, 2020
DEN180017Quantra Hemostasis Analyzer, QPlus CartridgeMarch 12, 2019