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

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    WINSTATION RETINAL IMAGER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PUNCH MYRINGOTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    ADVIA CENTAUR CEA AND BR ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DHX·June 27, 2008

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 28, 2013

    ABVISER-INTRA ABD PRESSURE MONITOR DEVICE

    FDA Adverse Event
    Malfunction ·CONVATEC INC·Product code FEN·July 24, 2014

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 2, 2011

    ASCENT SYSTEM-BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016

    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