BEUDAMED
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    iFuse TORQ TNT™ Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AXE D'ANTEVERSION POUR IMPACTEUR DE COTYLE

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489415043·

    16PW - Loggers - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506057816·OLD STYLE GREENBERG BLADE 4" X 5/8"

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776396442·Greenberg Retractor Blade, malleable, 5/8" x 4"

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277125040·Auerbach Rake Chain Retractor 4-Prong

    Broach 50 size 4

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055493·

    BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 2, 2019

    OSSEOTITE® IMPLANT 4 X 13MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code DZE·April 9, 2019

    T-8000 THEROZONE UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM 9.75 CM NON US

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·November 17, 2008

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 27, 2011

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 22, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014