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    Isomedix Operations Inc.

    FDA registration
    Isomedix Operations Inc.·2 products·🇺🇸 United States

    2008K@HOME HEMODIALYSIS MACHINE

    FDA registration
    ERIKA DE REYNOSA, S.A. DE C.V.·2 products·🇲🇽 Mexico

    Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set

    FDA registration
    Sterigenics Radiation Technologies Canada, Inc·2 products·🇨🇦 Canada

    PRISMA

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

    ALERTWATCH: OR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    END 200 Endoscopic Tubeset

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

    LOW PROFILE GASTROMSTOMY DEVICE

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

    ECG App

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Irregular Rhythm Notification Feature

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EndoFLIP® System with FLIP Topography module

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

    EsoFLIP® ES-310 Balloon Catheter

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

    PKIT, INSITE, GENTLE TOUCH (1/EA)

    Device
    EU MDR · Eu Md Class 1 ·Mizuho Orthopedic Systems, Inc.·On the market

    PKIT, RWF, NO PILLOW, 1/EA

    Device
    EU MDR · Eu Md Class 1 ·Mizuho Orthopedic Systems, Inc.·On the market

    PKIT, RWF, APV CUSHION, 1/EA

    Device
    EU MDR · Eu Md Class 1 ·Mizuho Orthopedic Systems, Inc.·On the market

    KENS INTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MASK, SURGICAL, DISPOSABLE

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

    CBEMED INDÚSTRIA E COMÉRCIO DE EQUIPAMENTOS MÉDICOS LTDA

    Manufacturer
    🇧🇷 Brazil

    3R Indústria E Comércio LTDA

    Manufacturer
    🇧🇷 Brazil·9 Basic UDI-DIs·674 Devices·1 Importer

    Animati Sistemas de Informática Ltda

    Manufacturer
    🇧🇷 Brazil

    IONIC HEALTH TECHNOLOGIES S.A.

    Manufacturer
    🇧🇷 Brazil·1 Basic UDI-DI·1 Device