BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Denture Base Resin (PN-Denture (Red, White))

    FDA 510(k)
    FDA Class 2 ·Dental

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMF·August 29, 2022

    IVAS 8 GAUGE BONE BIOPSY KIT

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

    SMS Cementless Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022

    IMP,TSV,MCOL MG,3.7MM,10M

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·May 8, 2026

    IMP,TSV,MCOL MG,3.7MM,10M

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·May 8, 2026

    BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 14, 2018

    STENOSCOPE 900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 19, 2008

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024

    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