BEUDAMED
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    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Recall
    Terminated ·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017

    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 17, 2012

    CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 17, 2012

    CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·May 22, 2012

    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·May 22, 2012

    TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·May 22, 2012

    TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 17, 2012

    VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQY·December 7, 2004

    Pereyra-Raz Ligature Carrier

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 21, 2017

    Pereyra-Raz Ligature Carrier

    FDA Recall
    Terminated ·Cook Inc.·Product code GEJ·April 25, 2017

    Raindrop Near Vision Inlay, Model# RD1-1

    FDA Enforcement
    Class II ·Terminated·Revision Optics Inc·March 29, 2017

    CYTO-STAT tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·September 16, 2010

    CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GKZ·September 16, 2010

    Raindrop Near Vision Inlay, Model# RD1-1

    FDA Recall
    Terminated ·Revision Optics Inc·Product code LQE·February 7, 2017

    Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·August 26, 2003

    Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

    FDA Enforcement
    Class I ·Terminated·RVO 2.0, INC·March 13, 2019

    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

    FDA Recall
    Terminated ·RVO 2.0, INC·Product code LQE·November 13, 2018

    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc.·July 8, 2020

    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020