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    OxyMask™ Aerosol

    FDA UDI
    Southmedic Incorporated·10620974000348·OxyMask Kit with Nebulizer

    OrhtoMTA Needle Tips

    FDA UDI
    BioMTA·08800027200085·Disposable and bendable and it is compatible wi...

    Rectangular Carving Block 2.0

    FDA UDI
    IMPLANTECH ASSOCIATES, INC.·M724BL20OMNS1·Rectangular Carving Block 2.0, Opaque, Medium

    OMN THR'D CUP SHELL ATC

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code MEH·September 24, 2003

    OMN THR'D CUP SHELL ATC

    FDA Adverse Event
    Injury ·HOWMEDICA INC.·Product code MEH·January 26, 2001

    OMN THR'D CUP SHELL ATC

    FDA Adverse Event
    Injury ·HOWMEDICA INC.·Product code MEH·January 26, 2001

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Malfunction ·OMN LIFE SCIENCE, INC.·Product code KWY·December 29, 2008

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMN LIFE SCIENCE INC.·Product code KWY·October 24, 2006

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMN LIFE SCIENCE INC·Product code KWY·October 16, 2007

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMN LIFE SCIENCE INC·Product code LPH·December 21, 2007

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMN LIFE SCIENCE, INC.·Product code KWY·May 28, 2008

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMN LIFE SCIENCE, INC.·Product code KWY·September 29, 2008

    IMPLANT: HA, 8MM INTEGRAL OMN LOC, 3.25

    FDA Adverse Event
    Injury ·CALCITEK·Product code DZE·October 3, 1996

    VALIANT NAVION

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·November 7, 2024

    SPHERO FLEX

    FDA UDI
    RHEIN 83 SRL·08059224018362·The OT Equator is designed as an endosseous den...

    PERSONA FEMORAL PROVISIONAL LEFT SIZE 4

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 9, 2017

    PERSONA FEMORAL PROVISIONAL LEFT SIZE 11

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 9, 2017

    PERSONA FEMORAL PROVISIONAL LEFT SIZE 10

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 9, 2017

    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

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·September 9, 2024