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

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    ABRM CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094317·2.5mm Screwdriver

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707052270·.022 EDGE UL MINI TUBE DIST EXT HK

    Disposable Balloon Catheter B5-2C

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EBI TROCHANTERIC NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    METRX

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 8, 2013

    ROUND FLUTED BUR, REGULAR

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD.·Product code HBE·December 8, 2010

    FRESENIUS 2008K

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 27, 2014

    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