BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    AirFit N20

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SULCUS BLUE

    FDA 510(k)
    FDA Unclassified ·Unknown

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 11, 2011

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 3, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 10, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040

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