BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756281379·PLASTIC PROCEDURE

    BACTEC BACTERIAL DETECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ENGAGE/ENGAGE TR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G7 NEUTRAL E1 LINER 32MM C

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·April 6, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 24, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·November 3, 2010

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·December 20, 2012

    G7 BISPHERICAL SHELL 48C

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·April 15, 2021

    PLASTIC PROCEDURE

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code LRO·October 15, 2020

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012