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

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    VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·April 20, 2017

    VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·June 21, 2017

    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020