BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PLASTIC OPTICAL LENS M-110

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODEL 490-01 PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ECEHLON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 10, 2014

    PLATE, 8 HOLE JL

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·December 10, 2012

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 12, 2010

    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