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

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    NeuroStar Advanced Therapy System (Version 3.8)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DeepXray

    FDA 510(k)
    FDA Class 2 ·Radiology

    NDI PASSIVE SPHERES

    FDA 510(k)
    FDA Class 2 ·Neurology

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·November 6, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 18, 2013

    PI DRIVE MOTOR

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·November 18, 2015

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code KNT·June 12, 2024

    Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·March 30, 2016

    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015