BEUDAMED
    500 results · 94ms · Sources: EU EUDAMED, US FDA

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    Ultra Bili Light

    FDA UDI
    PHYSICIAN ENGINEERED PRODUCTS INC·00183415000107·

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Recall
    Terminated ·Physician Engineered Products, Inc.·Product code LBI·August 31, 2013

    BRIGHT EMBRACE MODEL SBL60

    FDA Adverse Event
    Death ·PHYSICIAN ENGINEERED PRODUCTS, INC.·Product code LBI·September 5, 2013

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·August 4, 2023

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·June 29, 2022

    STAR

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LZS·September 10, 2020

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER (ISRAEL) LTD.·Product code DQK·March 2, 2017

    UNK

    FDA Adverse Event
    Malfunction ·ORTHOLOGIC CORP.·Product code LOF·January 14, 1999

    VITROS 5600 INTEGRATED SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 18, 2010

    GALAXY G3 MINI 2.00MM X 4.00CM

    FDA Adverse Event
    Malfunction ·REFER TO SECTION H10·Product code KRD·February 12, 2018

    UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 28, 2007

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·January 10, 2022

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·January 10, 2022

    CARTO 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·February 19, 2025

    DA VINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

    COULTER LH 750

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code GKZ·August 23, 2007

    AIA-900

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·March 22, 2018

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·January 22, 2008

    DELTAFILL18 24MM X 60CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 22, 2019