BEUDAMED
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    GEL-ONE

    FDA Adverse Event
    Injury ·SEIKAGAKU CORPORATION·Product code MOZ·January 24, 2018

    E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code OAH·June 8, 2010

    Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

    FDA classification
    FDA Class 1 ·Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

    Mighty Oak Medical

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·17 Devices

    Noah Labs GmbH

    Manufacturer
    🇩🇪 Germany

    MAH OPORNICE Alojzija Hrovat s.p.

    Manufacturer
    🇸🇮 Slovenia

    Mah Sing Healthcare Sdn Bhd

    Manufacturer
    🇲🇾 Malaysia·1 Basic UDI-DI·4 Devices

    P300-1AHS

    FDA UDI
    NAKANISHI INC.·04589551353989·

    OAK RIDGE PRODUCTS

    FDA registration
    OAK RIDGE PRODUCTS·4 products·🇺🇸 United States

    Mighty Oak Medical

    FDA registration
    Mighty Oak Medical·3 products·🇺🇸 United States

    NOAH MEDICAL Corp.

    FDA registration
    NOAH MEDICAL Corp.·1 product·🇺🇸 United States

    NOAH MEDICAL Corp.

    FDA registration
    NOAH MEDICAL Corp.·1 product·🇺🇸 United States

    NOAH MEDICAL Corp.

    FDA registration
    NOAH MEDICAL Corp.·1 product·🇺🇸 United States

    AAHS HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    WHITE OAK ORTHODONTIC PRODUCTS

    FDA registration
    WHITE OAK ORTHODONTIC PRODUCTS·22 products·🇺🇸 United States

    POST OAK INNOVATIONS, INC.

    FDA registration
    POST OAK INNOVATIONS, INC.·1 product·🇺🇸 United States

    NeoMass CAH

    Device
    EU IVDD · Eu Ivd General ·Labsystems Diagnostics Oy·On the market

    ORIF - CAH

    Device
    EU MDR · Eu Md Class 1 ·On the market

    MAH SING HEALTHCARE SDN BHD

    FDA registration
    MAH SING HEALTHCARE SDN BHD·4 products·🇲🇾 Malaysia

    SAADAT

    Device
    EU MDR · Eu Md Class 2b ·Pooyandegan rah saadat·On the market·2 countries