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

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

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 7, 2022

    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 7, 2022

    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·June 17, 2020

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·April 27, 2022

    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·September 7, 2022

    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

    FDA Enforcement
    Class II ·Ongoing·Qiagen Sciences LLC·April 27, 2022

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·February 3, 2021

    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    FDA Enforcement
    Class II ·Ongoing·Qiagen GmbH·October 11, 2023