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

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    AART CHIN IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cook

    FDA UDI
    COOK INCORPORATED·00827002161566·Open-End Tapered Tip Ureteral Catheter (Right)

    UP - Vehicle - 380-55230 - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal

    BD SMARTSITE NEEDLE-FREE CONNECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·November 9, 2021

    ULTRASOUND SCANNER, TYPE 2102

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONTRAK TESTCUP 502, MODEL 3016641

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MBT POR KEEL TIB TRAY SZ2

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code NJL·March 26, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·February 8, 2011

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·March 24, 2008

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023