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

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    Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573021482·INTRG WHISP MBT 1BIC HK-12T 0A 018 LL

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111162053·SKLIT SKLCT OP SCIS ST SB 5.5

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·May 30, 2017

    DIGITAL ELECTROCARDIOGRAPHS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760

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

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 25, 2011

    VA LOCKSCR Ø2.4 SELF-TAP L24 TAN

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·July 17, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 13, 2019

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 26, 2020

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025