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Haemonetics Corporation

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories2
Latest FDA decision2025-01-15
TypeNumberDevice NameCodeDateActions
510(k) K243858 TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA2025-01-15 View
510(k) K232018 Citrated: K, KH, RTH, FFHJPA2024-03-29 View
510(k) K221722 Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC2022-11-15 View
510(k) K183160 TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA2019-05-09 View
510(k) K160502 TEG 6s Hemostasis SystemJPA2017-04-19 View
510(k) K162423 Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC2017-01-03 View
510(k) K160197 Haemonetics Cell Saver Elite Autotransfusion SystemCAC2016-05-24 View
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