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

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    VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zuma

    FDA UDI
    Seaspine Orthopedics Corporation·10889981097479·Modular Bullet Paddle Distractor 16mm

    ORTHOVISION TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    COULTER® ACT DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC·Product code GKZ·December 7, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 11, 2013

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 24, 2014

    SHARPS CONTAINER

    FDA Adverse Event
    Malfunction ·POST MEDICAL, INC.·Product code FMI·March 12, 2024

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 14, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 15, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

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