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

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    DIRECT BILIRUBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ProMIS™ Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·March 6, 2014

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·September 8, 2010

    ADELANTE BREEZEWAY

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·November 11, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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