BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    SPORT SUPPORTS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788220220·12mm Lumbar Smooth Distractor

    24M - Class A Select 21 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620220·24M - Class A Select 21 - Metal

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWC·March 3, 2017

    JOSTRA VENT CATHETERS, MODELS LV & HKV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATHEROEDGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWC·March 3, 2017

    T25 STARDRIVE SHAFT F/MATRIX LONG

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·May 20, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·October 9, 2012

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 1, 2010

    IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 27, 2016

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021