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

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    TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Humelock TiN Coated Glenosphere

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·September 17, 2021

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 6, 2013

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

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