BEUDAMED
    32 results · 65ms · Sources: EU EUDAMED, US FDA

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    X-STOP

    FDA Adverse Event
    Death ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC·Product code NQO·January 16, 2008

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·August 14, 2019

    QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501

    FDA Recall
    Terminated ·St. Francis Medical Technologies Inc·Product code NQO·June 6, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·February 2, 2007

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·November 28, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·November 27, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC·Product code NQO·November 30, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 29, 2006

    X STOPPK IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 21, 2006

    X STOPPK IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 21, 2006

    X STOPPK IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC·Product code NQO·December 21, 2006

    X STOPPK IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 21, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 21, 2006

    X STOPPK IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 21, 2006

    X STOPPK IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·December 20, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·June 30, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·July 13, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·August 21, 2006

    X STOP IPD SYSTEM

    FDA Adverse Event
    Other ·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Product code NQO·July 31, 2006