BEUDAMED
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    CLEARVIEW TOTAL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CLEARVIEW UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

    GYMFORM DUAL FLEX BELT MODEL WB-162

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA SYSTEM S.P.A.

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

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·July 22, 2022

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    CARELINK

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

    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