BEUDAMED
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    Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

    FDA Recall
    Open, Classified ·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·May 22, 2020

    CryoValve Heart-valve, allograft

    FDA Recall
    Terminated ·Cryolife Inc·Product code LMO·March 19, 2003

    CryoValve Heart-valve, allograft

    FDA Recall
    Terminated ·Cryolife Inc·Product code LMO·March 19, 2003

    nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers

    FDA Recall
    Completed ·Product code IYE·July 12, 2023

    Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code JMO·March 14, 2008

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018

    VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JMO·May 14, 2024

    UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JMO·June 26, 2025

    VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JMO·May 24, 2016

    Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JMO·December 16, 2009

    Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JMO·December 20, 2012