BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    Mould Probe MR Safe

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRISTAR BONE GRAFT FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    THE VITROS 5,1 FS CHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    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

    SECURE II MED/SURG BED

    FDA Adverse Event
    Injury ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·November 19, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·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

    MECTACER BIOLOX OPTION HEADS

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

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

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

    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