BEUDAMED
    11 results · 12ms · Sources: EU EUDAMED, US FDA

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    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·April 13, 2016

    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 13, 2016

    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·April 13, 2016

    Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 20, 2018

    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·December 15, 2014

    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·December 15, 2014

    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·December 15, 2014

    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·December 15, 2014

    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JGJ·December 8, 2021