BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    SYSTEM 1E Liquid Chemical Sterilant Processing System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFINITI CYP2C19 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 14, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008

    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