BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·July 12, 2017

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 2, 2017

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 1, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·June 20, 2013

    TRUPATH BIOPSY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·September 23, 2008

    BELLAFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·TIGER AESTHETICS MEDICAL LLC·Product code LMH·September 24, 2025

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    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