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

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    COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH

    FDA 510(k)
    FDA Class 1 ·Radiology

    Cortera

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311209316·Guidewire, SS, Blunt Tip, 550

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665586896·MIS Cannulated Screw M, Ø10.5 x 50mm, Ø5.5mm Rod

    ORTHOHUB EXTERNAL FIXATOR SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELEVATE PROLAPSE REPAIR SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 30, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 9, 2010

    UNKNOWN_FRO_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code HWC·July 17, 2014

    PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM, P/N 0250080590 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