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

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    E-CUBE

    FDA 510(k)
    FDA Class 1 ·Dental

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026216·microSelectron Transfer Tube for 5F Flexibles (20)

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321116160·

    INDUO BLOOD GLUCOSE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THE GRAPPLR AND GRAPPLR EXTENDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 6, 2013

    S-ROM SLEEVE PRX ZTT, 14B-LRG

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MRA·May 13, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·August 13, 2008

    Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021