BEUDAMED
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    SmartLinx Vitals Plus Patient Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FIXATION TROCARS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NMI 2.8 MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    FDA Adverse Event
    Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    T-HANDLE W/RATCHET-WRENCH+W/TORQ LIMIT 1

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code LXH·June 22, 2013

    CHEMSTRIP® 10 UA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JIL·July 29, 2011

    PHOTOFIX PATCH - 6CM X 8CM

    FDA Adverse Event
    Injury ·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021

    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

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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