BEUDAMED
    15 results · 18ms · Sources: EU EUDAMED, US FDA

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    SYNCHRON URIC ACID

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code KNK·June 10, 2011

    SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SMARTMONITOR 2PS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TheraCem

    FDA 510(k)
    FDA Class 2 ·Dental

    GDC POWER SUPPLY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010

    SMARTMONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·January 18, 2013

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·January 11, 2011

    SMARTMONITOR 2 PROFESSIONAL SERIES

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024