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

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    CLEAR IMAGE ALIGNER

    FDA 510(k)
    FDA Class 2 ·Dental

    Gibson Healthcare

    FDA UDI
    BENCO DENTAL SUPPLY CO.·D74440719701·BENCO C6 3-0 CH GUT 18"/45CM

    NOBELACTIVE INTERNAL NP 3.5X11.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 13, 2020

    NOBELACTIVE INTERNAL RP 4.3X10MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020

    NOBELACTIVE INTERNAL NP 3.5X11.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 13, 2020

    BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    JET 1 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 30, 2021

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 22, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    HYPOINT NDL27GA1/2IN

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·May 12, 2020

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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

    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