BEUDAMED
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    MEDICAL DEVICE INTEGRATER SMARTLINX AXON 110

    FDA Adverse Event
    Malfunction ·CAPSULE TECH, INC.·Product code MHX·November 18, 2021

    Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System. Catalog Number: DC-NU-MPC Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data that can local cache data and connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network, available in a fixed or mobile mounting option, running either DataCaptor continuous or periodic connectivity software The DataCaptor" System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor" is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to

    FDA Recall
    Terminated ·Capsule Tech Inc.·Product code MWI·August 25, 2010

    Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.

    FDA Recall
    Terminated ·Capsule Tech Inc.·Product code MWI·August 10, 2012

    Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.

    FDA Enforcement
    Class II ·Terminated·Capsule Tech Inc.·September 19, 2012

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD.·Product code LXS·June 11, 2015

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code MJP·December 5, 2023

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·July 2, 2024

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code MJP·November 22, 2024

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code HQL·February 6, 2021

    SENSAR IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·May 7, 2024