BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    SIMPLICARE TRANSPARENT WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517676870·Monolith Core, Ø12x14mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198987·AK3 Congruent Insert Trial Size 2, 14mm

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G5869912140·instrument id roll tape, withstands repeated st...

    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JO Premium Jelly Original Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EXTENSION SET 30IN

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code FPA·June 3, 2009

    APM/AIM PUMP SET W/C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010

    OPEN SPINE ANGLED CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 14, 2013

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·March 6, 2013

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·February 15, 2011

    REVEAL LINQ

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code DSI·August 8, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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