BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    UC QIK 1-STEP HCG TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Entriport

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OPERATING CYSTOSCOPE-URETHROSCOPE

    FDA Adverse Event
    Death ·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·December 30, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 17, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021