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

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    DenMat Glutaraldehyde Desensitizer

    FDA 510(k)
    FDA Class 2 ·Dental

    SetX 13mmX12mm Cervical Rasp 5mm, 6mm, 7mm

    FDA UDI
    XENCO MEDICAL LLC·B064XM12223571·

    TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MERITS MODEL P322FWD POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·November 9, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    NOVOFINE (32G) (NEEDLE) N/A

    FDA Adverse Event
    Other ·NOVO NORDISK A/S MEDICAL SYSTEMS·Product code FMI·August 18, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CEM·July 12, 2013

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

    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