BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Break Wave

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QMN·August 3, 2022

    NA

    FDA UDI
    Exactech, Inc.·10885862552471·TIBIAL SHIM, SZ 5/6 13 MM

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·March 2, 2022

    IGNITE BONE VOID FILLER KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2025

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·March 2, 2022

    PERSONA PEGGED POROUS TIBIAL PLATE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code OIY·November 12, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2011

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 29, 2013

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·February 14, 2022

    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