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

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    VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Alteon

    FDA UDI
    Exactech, Inc.·10885862607294·

    ATRIUM LITE MESH

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

    AETMED IMAGE PROCESSING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    EZ-28 DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code MSS·April 3, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    MCA MED APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·April 6, 2011

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014