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

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    SYN-02 PN AMPLIFIER

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

    TwinFix

    FDA UDI
    Stryker GmbH·04546540362117·CANNULATED COMPRESSION SCREW

    MERON APPLICATION CAPSULES

    FDA 510(k)
    FDA Class 2 ·Dental

    ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·March 6, 2019

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 14, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 13, 2012

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018