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

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    Response Ortho Metaphyseal Hinge Fixator System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cavetto [MAX] Cervical Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARIS TRANS-OBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTN·November 6, 2019

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2025

    DOUBLE MOBILITY LINER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 30, 2026

    TI RIGID PLATE TWO LEVEL

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·November 20, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·September 9, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 22, 2013

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

    AMISTEM-P COLLARED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 29, 2025

    DM CONVERTER ¿ TIN COATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2026

    HOLDING SLEEVE 55MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FZX·May 19, 2016

    MECTACER BIOLOX OPTION HEADS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025

    HOLDING SLEEVE 55MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 19, 2016

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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