2 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·April 10, 2024
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)
FDA Enforcement
Class III
·Ongoing·Helena Laboratories, Corp.·December 4, 2019