BEUDAMED
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    COAG-1 PT-NC TEST CARD

    FDA 510(k)
    FDA Class 2 ·Hematology

    ORTH-EVAC TM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THROMBOPLASTIN.C PLUS

    FDA 510(k)
    FDA Class 2 ·Hematology

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 9, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·July 1, 2014

    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MYA·August 2, 2018

    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 7, 2025