BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    NEXA CARPO METACARPAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

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

    DUO-DENT DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    3004068499-2017-00002

    FDA Adverse Event
    Malfunction ·February 10, 2017

    SPS PRESERVATION SOLUTION

    FDA Adverse Event
    Injury ·ORGAN RECOVERY SYSTEMS·Product code KDN·January 11, 2017

    SPS-1

    FDA Adverse Event
    Injury ·ORGAN RECOVERY SYSTEMS·Product code KDN·February 2, 2017

    3004068499-2017-00003

    FDA Adverse Event
    Malfunction ·February 10, 2017

    SPS-1

    FDA Adverse Event
    Malfunction ·ORGAN RECOVERY SYSTEMS INC·Product code KDL·January 30, 2017

    SPS-1

    FDA Adverse Event
    Malfunction ·ORGAN RECOVERY SYSTEMS, INC.·Product code KDL·January 30, 2017

    3004068499-2017-00001

    FDA Adverse Event
    Malfunction ·February 10, 2017

    SPS-1

    FDA Adverse Event
    Injury ·ORGAN RECOVERY SYSTEMS·Product code KDL·February 3, 2017

    3004068499-2017-00004

    FDA Adverse Event
    Malfunction ·February 10, 2017

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 10, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·April 15, 2011

    ZENITH AAA MAIN BODY DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·June 12, 2008

    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143

    FDA Enforcement
    Class II ·Terminated·Organ Recovery Systems, Inc.·February 8, 2017

    SPS STATIC PRESERVATION SOLUTION

    FDA Adverse Event
    Malfunction ·ORGAN RECOVERY SYSTEMS, INC.·Product code KDL·February 1, 2017

    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143

    FDA Recall
    Terminated ·Organ Recovery Systems, Inc.·Product code KDL·December 14, 2016

    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