BEUDAMED
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    APEX UNIVERSAL ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093631·

    5131043

    FDA Adverse Event
    Malfunction ·October 7, 2015

    ECT DIGITAL THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    D-10 HEMOGLOBIN A1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 14, 2026

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 23, 2020

    PELVICOL 6 X 8 CM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·May 21, 2013

    PACEART SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DPS·June 16, 2011

    PULSE GEN MODEL 102

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

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019

    Universal Nerve Block Tray Catalog Number: 9818

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 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