BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    SERALYZER HEMOGLOBIN TEST MODULE

    FDA 510(k)
    FDA Class 2 ·Hematology

    Traverse

    FDA UDI
    Nuvasive, Inc.·00887517154408·Traverse Plate, 45mm 2-Bolt

    LOQTEQ®

    FDA UDI
    aap Implantate AG·04042409346040·LOQTEQ Screw guide sleeve 4.5, red

    Wearable Breast Pump (Model S1DW)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID

    FDA 510(k)
    FDA Class 2 ·Microbiology

    M2A 38MMX64 MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    CARE ASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·October 10, 2012

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·August 20, 2010

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    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