BEUDAMED
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    OMNIgene GUT Dx

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CCC CROWN-CORE-CUT-NEEDLE

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

    HIGH SPEED CORE CUT BIOPSY GUN

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

    CUTTING WHEEL

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·OrthoPediatrics Canada ULC·1 device

    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Imaging Group·August 29, 2012

    Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

    FDA Enforcement
    Class II ·Terminated·Southmedic, Inc.·May 23, 2018

    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs

    FDA Enforcement
    Class II ·Terminated·Pyng Medical Corporation·November 11, 2015