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

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    CREATINE KINASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DeltaForm HD

    FDA UDI
    Merz Dental GmbH·D7091980012·DeltaForm HighDefinition posterior; shade A2; s...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690110415·Steinman Pin with Innomed End

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·NOVACOR LVAS

    PLATELIA LYME IGG ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ANTITHROMBIN III RIA

    FDA 510(k)
    FDA Class 2 ·Hematology

    9800 12

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 7, 2011

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·NOVACOR N100PCQ LVAS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·WORLD HEART NOVACOR N100PC AND N100PCQ :VAS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·NOVACOR LVAS

    OEC 9800 12

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

    OEC 9800 12 STANDAR

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2010

    ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2014

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·January 24, 2011

    9800 12 STD C ARM SP GSP ESP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 12, 2010

    ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code KWR·November 28, 2012