BEUDAMED
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    CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·August 12, 2009

    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·August 26, 2015

    CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

    FDA Enforcement
    Class II ·Terminated·Menarini Silicon Biosystems·May 2, 2018

    CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

    FDA Recall
    Terminated ·Menarini Silicon Biosystems·Product code NQI·April 4, 2018

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code GEH·March 9, 2015

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code JGS·December 9, 2019

    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 5, 2020

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·August 22, 2018