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

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    UTAK-STABBS TOXICOLOGY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Sysmex Automated Blood Coagulation Analyzer CS-5100

    FDA 510(k)
    FDA Class 2 ·Hematology

    5F SHERPA ACTIVE NX GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 10, 2012

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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