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

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    DIVERGENCE Anterior Cervical Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741424500·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674142450060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1424500·14mm H x 24mm W x 50mm L x 0 degrees XLIF

    i-ED COIL

    FDA UDI
    KANEKA CORPORATION·04540778177796·The i-ED COIL is used for vascular embolization...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X142450120·14mm H x 24mm W x 50mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14245080·14mm H x 24mm W x 50mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L142450120·14mm H x 24mm W x 50mm L XLIF Trial 12 degree L...

    STERRAD NX CHALLENGE PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IONOLUX PRO

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JMG·June 3, 2013

    3.7MM CANNULATED LOCKING SCREW

    FDA Adverse Event
    Death ·SYNTHES MONUMENT·Product code KTT·June 17, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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