BEUDAMED
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    POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER

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

    HHM

    FDA UDI
    Oticon A/S·05707131261663·H100, BTE 13 WL 85 SGR HHM

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·June 9, 2025

    THE SENSITITRE AIM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EVOLVE RADIAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO MEDICAL EQUIPMENT·Product code IOR·May 29, 2013

    SELUTE PICOTIP

    FDA Adverse Event
    Death ·CPI - DEL CARIBE·Product code NVN·June 20, 2011

    KAPPA SR. 700

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code DXY·August 22, 2008

    BD PYXIS¿ ANESTHESIA STATION ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·February 4, 2026

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015