BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    VISOPROTECT: OCCULAR SHIELD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994414632·LID 1850099 GENERIC IMPLANT TRAY LID

    SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HRS·January 30, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 4, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 26, 2012

    TOTALCARE-TREAT SURFACE&SCALE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·September 28, 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