BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    PLANET Onco Dose (3.2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SmartHDM-510 System

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

    FDR D-EVO FLAT PANEL DETECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    ZENITH AAA ENDOVASCULAR GRAFT ILLIAC LEG

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·November 19, 2008

    COLLEAGUE

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

    TOTAL ASR ACET IMP SIZE 52

    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