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

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    Unite Connect for Clinical Systems

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMPREHENSIVE SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304677326·

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019

    VIBERECT PENILE VIBRATORY STIMULATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    O2PAK OXYGEN GENERATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GM HELIX IMPLANT 6.0X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019

    GM HELIX ACQUA IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·June 20, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 27, 2011

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    FDA Adverse Event
    Malfunction ·FLIGHT MEDICAL LTD.·Product code CBK·June 30, 2008

    GM HELIX IMPLANT 6.0X8

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019

    DURAN ANCORE BAND

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 19, 2019

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023