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

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    NuVasive® Cohere® Thoracolumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORTRAK* 2 Enteral Access System

    FDA UDI
    Avanos Medical, Inc.·00350770456508·Replacement Li-Ion Battery Pack

    DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COCR HEAD 28/+4 'L' 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code MEH·January 26, 2026

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 1, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    2520274-2014-00723

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code KTT·February 20, 2014

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021