BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    CHIRON DIAGNOSTICS ACS: 180 FOLATE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NONE

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code UNK·December 11, 2009

    Cartesion Prime

    FDA 510(k)
    FDA Class 2 ·Radiology

    GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·December 11, 2009

    FLEXIMA¿ APDL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FFA·March 6, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 7, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·August 8, 2014

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021