BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·June 12, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 11, 2013

    OPTISENSE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

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