BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIEWFLEX PLUS ICE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 21, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 8, 2011

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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