BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196396·AK3 Femoral Instruments Pan

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195108·AK3 Femoral Instruments Pan Insert

    ATRIUM C-QUR OVT MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SALTO TALARIS TOTAL ANKLE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLUS SL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·October 7, 2008

    CLINITEK STATUS

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code KQO·June 20, 2013

    MAXPLUS EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·June 29, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012