BEUDAMED
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    Invictus® Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182277·

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CorPath GRX System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 10, 2009

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·November 6, 2014

    UTERINE MANIPULATOR - 7CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LKF·September 2, 2011

    QUANTA SYSTEM

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025