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    POM Medical, LLC

    Manufacturer
    🇺🇸 United States·1 Importer

    POM Medical, LLC

    FDA registration
    POM Medical, LLC·1 product·🇺🇸 United States

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Recall
    Terminated ·POM Medical LLC·Product code BYG·July 11, 2018

    POM

    FDA Adverse Event
    Malfunction ·POM MEDICAL, LLC.·Product code BYG·August 14, 2018

    POM

    FDA Adverse Event
    Malfunction ·POM MEDICAL, LLC.·Product code BYG·August 14, 2018

    POM

    FDA Adverse Event
    Malfunction ·POM MEDICAL, LLC.·Product code BYG·August 14, 2018

    POM

    FDA Adverse Event
    Malfunction ·POM MEDICAL, LLC.·Product code BYG·August 14, 2018

    CURAPLEX / POM

    FDA Adverse Event
    Malfunction ·POM MEDICAL, LLC.·Product code BYG·August 14, 2018

    POM

    FDA Adverse Event
    Malfunction ·POM MEDICAL, LLC.·Product code BYG·August 14, 2018

    Novamedisan Italia Srl

    Importer
    🇮🇹 Italy·5 Manufacturers

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices

    SANGUESA SA

    Importer
    🇪🇸 Spain·10 Manufacturers

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices