BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    REVIAN RED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VERSARATE FLOW RATE CONTROLER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFILL INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 15, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·June 17, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    SUREFORM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GDW·July 28, 2020

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx

    FDA Enforcement
    Class II ·Ongoing·Enchroma Inc·November 27, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

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