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

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    AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RELIANCE SPINAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zenius™, Iliad™ and Kora™ Spinal Fixation Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KOG·April 16, 1998

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 8, 2011

    SENSOR HSA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·August 5, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

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