BEUDAMED
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    LIPID CONTROL PRODUCT # ACS LC 101

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TruForm

    FDA UDI
    Rmo, Inc.·00885797100016·MN 1MOL BD KT STD NO/L R&L 218

    0800,APS1,8,N,TV,VU,VD,CAU,CAD,NV,SF

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828153263·0800,APS1,8,N,TV,VU,VD,CAU,CAD,NV,SF

    NA

    FDA UDI
    Zimmer, Inc.·00889024144293·

    QUANTA SYSTEM S.P.A.

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

    SYNTHES (USA) WRIST FUSION PLATES (WFP)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIVONA ADULT TTS TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD,INC.·Product code JOH·March 28, 2020

    8015 ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 20, 2020

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 11, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 22, 2012

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·August 12, 2010

    regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    ZVU Functional GI Software, REF: ZVU-3

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·July 25, 2023

    BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DXN·April 2, 2008

    S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.

    FDA Recall
    Terminated ·GE Healthcare·Product code MSX·December 13, 2007

    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·June 4, 2025

    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·July 20, 2011

    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 16, 2013