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

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    ACCESS PROGESTERONE ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMULITE HS-TSH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICRUSPHERE 10 - PLATINUM MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·February 11, 2013

    COLIBRI

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code EKX·July 24, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 10, 2011

    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