BEUDAMED
    5 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 13, 2023

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·March 4, 2015

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Enforcement
    Class II ·Ongoing·NOA Medical Industries Inc·January 22, 2025