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

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    ISOLATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COPELAND RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GALAXY G3 MINI 2MM X 6CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 23, 2020

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·April 30, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012

    NONE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 29, 2008

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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