BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    AECD ARRHYTHMIA DETECTION SOFTWARE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PE/Cyanine7 anti-human CD7

    FDA UDI
    BIOLEGEND, INC.·00810034702326·URL: https://www.biolegend.com/en-us/products/p...

    Fetal Doppler, Model FD88

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET

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

    PROTÉGÉ ¿EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Injury ·EV3 INC.·Product code FGE·February 28, 2013

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 2, 2011

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 24, 2014

    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