BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    DADE FACTOR ASSAY REFERENCE PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    Traverse

    FDA UDI
    Nuvasive, Inc.·00887517153425·Traverse Plate, Size 85 Fixed

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209135738·

    Momentum

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386025928·Navigated tap, Ø 8.5mm, cannulated, 1/4"-square

    SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC IRELAND LTD.·Product code NIQ·February 25, 2009

    PLV-100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 2, 2014

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·November 6, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 23, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021