BEUDAMED
    113 results · 13ms · Sources: EU EUDAMED, US FDA

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    Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 13, 2022

    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 13, 2022

    Atellica IM 1600 Analyzer, SMN 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code JJE·September 28, 2021

    Atellica IM 1300 Analyzer, SMN 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code JJE·September 28, 2021

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023

    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code HWC·March 19, 2024

    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only

    FDA Recall
    Open, Classified ·TriMed Inc.·Product code HWC·March 19, 2024

    Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 3, 2022

    Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 3, 2022

    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 3, 2022

    Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024

    Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NIG·July 26, 2024