BEUDAMED
    44 results · 13ms · Sources: EU EUDAMED, US FDA

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    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .018" REF PMP 8-7-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .018" REF PMP 8-7-18-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 14mm 80 cm .018" REF PMP 8-5-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .018" REF PMP 8-5-18-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .014" REF PMP 4-7-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .014" REF PMP 4-7-18-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMP 4-5-18-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .014" REF PMP 4-6-21-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm 0.18" REF PMP 8-5-21-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 18mm 80 cm 0.14" REF PMP 4-6-18-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 14 80 cm .018" REF PMP 8-6-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm .014" REF PMP 4-5-21-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 14mm 80 cm .014" REF PMP 4-6-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    Proclaim DRG Implantable Pulse Generator, Model Number 3664

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code PMP·March 9, 2018

    Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 7, 2015

    RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

    FDA Enforcement
    Class II ·Terminated·Eizo Corporation·July 22, 2015

    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: ¿ Radiologists can view, annotate, and tag studies as diagnostically Read. ¿ Referring physicians can view patient images and radiologists annotations. ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·November 30, 2016

    RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

    FDA Enforcement
    Class II ·Terminated·Eizo Corporation·July 22, 2015