BEUDAMED
    3 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Regulation: Us FDA × Clear all

    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

    INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

    FDA Enforcement
    Class III ·Terminated·AAP Implantate Ag·January 1, 2020

    INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

    FDA Enforcement
    Class III ·Terminated·AAP Implantate Ag·January 1, 2020