BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    DTAD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HEMADERM COTAINING HEMADEX CLOTTING BEADS

    FDA 510(k)
    FDA Unclassified ·Unknown

    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWY·May 21, 2013

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 26, 2014

    DURALOC APEX HOLE ELIMINATOR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDL·June 2, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015