BEUDAMED
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    GE 3.0T GENERAL PURPOSE FLEX COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Graves Vu-More Medium

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030953·Graves Vu-More Medium 4 1/2" (114mm)

    DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VC10 PUMP, 115V

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

    BD SHARPS DISPOSAL

    FDA Adverse Event
    Malfunction ·BD MEDICAL, MEDICATION DELIVERY SOLUTIONS·Product code FMI·March 26, 2024

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·April 2, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·July 30, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·April 17, 2008

    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

    HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    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

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016