BEUDAMED
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    WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DRUGS OF ABUSE MULTI-TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 28, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORP·Product code FRN·March 21, 2014

    ETS FLEX ARTICNG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 28, 2011

    BD PHOENIX¿ NMIC-311

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ NMIC-311

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 28, 2026

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 14, 2026

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 27, 2026

    BD PHOENIX¿ NMIC-306

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 20, 2026

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Enforcement
    Class III ·Terminated·Focus Diagnostics Inc·November 7, 2012

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code NOP·October 3, 2012