BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    THYROXINE MICROASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODEL 476-03 PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    RECON-2 FLOW CONTROLLER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 27, 2010

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 21, 2012

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·April 21, 2017

    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