BEUDAMED
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    ADVANCED PERFUSION SYSTEM 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925018587·MINI MC GEE SMOOTH JAW FORCEPS

    Plateau-C Ti

    FDA UDI
    Life Spine, Inc.·00190837066550·16x13 Rasp/Trial 0 deg 11mm No Stop

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613110239·White Nylon Tube Brushes, 6Fr, Brush Diameter 6...

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776318574·Alligator Ear Forcep

    FLUENCY TRACHEOBRONCHIAL STENT GRAFT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015

    NUVASIVE GENERAL INSTRUMENTS

    FDA Adverse Event
    Injury ·NUVASIVE, INC.·Product code LXH·April 12, 2024

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·May 21, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 20, 2008

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 4, 2022

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    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