BEUDAMED
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    KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295236313·P.F.C. SIGMA POSTERIOR-LIPPED TIBIAL INSERT TRI...

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471149816·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.2mm DIA...

    s-Clean OneQ-SL Narrow Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    MUCOGRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    EMERALD

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·July 6, 2016

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 20, 2010

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 14, 2013

    Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

    FDA Enforcement
    Class I ·Ongoing·Pacific Medical Group Inc.·April 28, 2021