BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    DRUGS OF ABUSE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094515·Universal Sierra Counter Torque

    Longevity V-Lign®

    FDA UDI
    Zimmer, Inc.·00889024156623·

    Rachel's Remedy

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODIFICATION TO: EXPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 27, 2014

    DVR EPAK VOLAR RIM PLATE LEFT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·July 29, 2015

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 6, 2013

    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