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

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    GYRUS HYSTEROSCOPIC RESECTOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PROTRON TECHNOLOGIES, LLC STETHOTRON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISS-JAZZ Screw System and JAZZ CAP SP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IBALANCE TKA TIBIAL TRAY SIZE 2

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code JWH·July 26, 2016

    4.0MM TI CANNULATED SCREW LONG THREAD 54MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·February 28, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 9, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 24, 2014

    IBALANCE TKA FEMORAL IMPLANT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code JWH·July 26, 2016

    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