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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K002177
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Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a ... 2 02/19/2015 Haemonetics Corporation
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TE... 2 06/28/2022 Haemonetics Corporation
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 2 06/30/2022 Haemonetics Corporation
TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulatio... 2 03/21/2011 Haemoscope Division of Haemonetics Corp
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro... 2 07/24/2013 Haemonetics Corporation
TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastogra... 2 07/06/2011 Haemoscope Division of Haemonetics Corp
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4... 2 03/31/2020 Haemonetics Corporation
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