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    Omnyx, LLC

    Manufacturer
    🇺🇸 United States

    Dynamyx Digital Pathology Software

    FDA UDI
    OMNYX, LLC·00860007120206·Dynamyx Digital Pathology Software is intended ...

    OMNYX IDP SOFTWARE MEDIA BUNDLE VERSION 1.1

    FDA Adverse Event
    Malfunction ·OMNYX LLC·Product code OEO·October 21, 2013

    Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.

    FDA Recall
    Terminated ·Omnyx Llc·Product code OTU·October 1, 2013

    Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.

    FDA Enforcement
    Class II ·Terminated·Omnyx Llc·December 18, 2013

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    ONYX MEDICAL LLC

    FDA registration
    ONYX MEDICAL LLC·68 products·🇺🇸 United States

    ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin

    FDA Enforcement
    Class II ·Terminated·ProSun International, LLC·April 24, 2019

    ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin

    FDA Recall
    Terminated ·ProSun International, LLC·Product code LEJ·December 10, 2018

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 17, 2024