BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    ALICE 5

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIMENSION PENTA L

    FDA 510(k)
    FDA Class 2 ·Dental

    DJ ORTHOPEDICS INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KEEPSAFE FALL MONITOR

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·March 12, 2013

    ENDOURETEROTOMY STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL, INC.·Product code KOD·May 8, 2008

    CONTOUR CURVED CUTTER STAPLER

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

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 3, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 1, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 23, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 12, 2017

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 30, 2014

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 2, 2014

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·July 10, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·April 25, 2018

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·June 9, 2017

    33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 1, 2012

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 12, 2014