BEUDAMED
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    IRAS PERIMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LASER IRAS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Zephyr Patient Positioning and Transfer System

    FDA UDI
    Diacor, Inc.·B237ZXLIRA100·Zephyr IR Articulating Hoverboard with mounts f...

    IRAS GLARE TESTER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IRAS EDS INTERFEROMETRIC STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    COAT-A-COUNT AMIKACIN IRA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SION BLUE

    FDA Adverse Event
    Death ·ASAHI INTECC CO., LTD.·Product code DQX·February 5, 2024

    SION

    FDA Adverse Event
    Death ·ASAHI INTECC CO., LTD.·Product code DQX·February 5, 2024

    IRA-I CS RETRACTOR BODY

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GAD·November 14, 2013

    RA LEAD

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code DTB·August 12, 2023

    *

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS, INC.·Product code LJT·December 7, 2011

    OVITEX REINFORCED TISSUE MATRIX

    FDA Adverse Event
    Injury ·AROA BIOSURGERY·Product code FTM·February 28, 2024

    OVITEX REINFORCED TISSUE MATRIX

    FDA Adverse Event
    Injury ·AROA BIOSURGERY LTD.·Product code FTM·March 11, 2024

    PERMANENT PACEMAKER ELECTRODE

    FDA Adverse Event
    Malfunction ·PACESETTER/ ABBOTT MEDICAL·Product code DTB·February 28, 2025

    PERMANENT PACEMAKER ELECTRODE

    FDA Adverse Event
    Malfunction ·PACESETTER/ ABBOTT MEDICAL·Product code DTB·February 28, 2025

    CAPSUREFIX NOVUS LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code NVN·August 12, 2023

    PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    MRI LOW PROFILE PORT WITH ATTACHABLE 7 FR GROSHONG SINGLE-LUM

    FDA Adverse Event
    Death ·C. R. BARD INC. (BASD)·Product code LJT·September 28, 2010

    ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular