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

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    PENT CAPS

    FDA 510(k)
    FDA Class 2 ·Dental

    MRI Compatibility for Existing Straumann Dental Implant Systems

    FDA 510(k)
    FDA Class 2 ·Dental

    MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PDS II (POLYDIOXANONE) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code NEW·November 1, 2010

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 13, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·December 31, 2012

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·October 19, 2011

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 13, 2011

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    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