BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ultrasonic Surgical System

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GIALLOY CB/N

    FDA UDI
    SRL Dental GmbH·ESRL58902811·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 22, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 29, 2012

    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