BEUDAMED
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    CEI Pte Ltd

    FDA registration
    CEI Pte Ltd·1 product·🇸🇬 Singapore

    OPTISCAN MODEL OPTISCAN CEIS

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

    CEI Cutting Edge Instruments

    FDA UDI
    COLTENE/WHALEDENT INC·D661PTC57X1·FG57 CARB BUR 10PK

    NUTRILINE

    FDA Adverse Event
    Injury ·VYGON GMBH·Product code LJS·October 17, 2019

    ADVANCECE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC·Product code DXE·November 10, 2016

    7-DAY LL VLV ADPT(STAND ALONE)

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 11, 2021

    UNIFY ASSURA ICD

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC.·Product code NIK·February 23, 2017

    CEI Cutting Edge Instruments (PTC-57C)

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJL·October 20, 2020

    TLIF-C EI 12MM 8DEG 32/12

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·October 21, 2020

    TLIF-C EI 9MM 8DEG 32/10

    FDA Adverse Event
    Injury ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·January 5, 2024

    PROXIMA MI CALCAR REAMER SMALL

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code HTO·July 17, 2018

    CEI Cutting Edge Instruments (PTC-57C)

    FDA Enforcement
    Class II ·Ongoing·Coltene Whaledent Inc·November 25, 2020

    SORIN S5 SYSTEM

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DTQ·September 12, 2024

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code DRA·June 19, 2020

    TLIF-C EI H 9MM 0DEG 32/10

    FDA Adverse Event
    Injury ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 28, 2020

    GE SIGNA EXCITE 3.0T MR SYSTEM

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code LNH·October 2, 2025

    GE 3.0T SIGNA HDX MR SYSTEM

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code LNH·March 21, 2025

    NA

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS, LLC·Product code LNH·August 1, 2025

    MEDICAL COMPRESSOR

    FDA Adverse Event
    Malfunction ·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011

    NA

    FDA Adverse Event
    Injury ·GE HEALTHCARE (TIANJIN) COMPANY LIMITED·Product code LNH·December 12, 2024