BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    AOK 95A Medical Mask (20200049)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025033·G95 Mini Incubator

    ECHOSCAN, MODEL US-1800

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 29, 2008

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 23, 2011

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HTJ·July 11, 2013

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025