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

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    CYBEX 770

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    REUNITE® STEINMANN PIN

    FDA UDI
    Biomet Orthopedics, LLC·00880304416611·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117469·Distal Reamer (Hudson)

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111566·Modular Stem 9mm x 150mm

    ReDs Wearable System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    All-Suture Dual Anchor System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862195203·X-RAY TEMPLATE, LOGIC PS, SIZE 0-6

    TriVerse X-Ray Digital Template, Tibial Tray

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215114503·

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 8, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·December 7, 2010

    11G 5" MATCH-GROUND FOUR FACT TIP INTRODUCTION NEEDLE

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code KNW·July 22, 2014

    ANKLE LOCKING NAIL 10 X 150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSB·May 28, 2019

    STA Neoplastine CI Plus 10; Product Catalogue Number: 0667 Manufactured by Diagnostica Stago, Asnieres, France.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 20, 2008

    STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 20, 2008

    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