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    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294407·Insufflation Tubing Set with Filter, Ovate Conn...

    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294155·Insufflation Tubing Set with Filter, 12/22mm Co...

    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294087·LumaGuard: Light Shield for Fiber Optic Light C...

    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294377·Suction Tubing Set, 20.5' Length with Funnel Co...

    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294278·Dual Chamber Scope Warmer that Pre-Warms Multip...

    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294445·Insufflation Tubing Set with Filter, Ovate Conn...

    JosNoe Medical Inc

    FDA UDI
    JOSNOE MEDICAL, INC.·00850003294254·Bulk, Non-Sterile Insufflation Tubing Set with ...

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JNM·September 7, 2011

    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code JNM·August 24, 2016

    Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code JNM·November 1, 2018

    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code JNM·January 20, 2021

    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

    Immunochemical, Transferrin

    FDA classification
    FDA Class 2 ·Immunochemical, Transferrin

    HNM Medical dba HNM TOTAL RECON

    FDA registration
    HNM Medical dba HNM TOTAL RECON·212 products·🇺🇸 United States

    OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1

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

    INMED GLOVES FACTORY

    FDA registration
    INMED GLOVES FACTORY·2 products·🇨🇳 China

    ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

    FDA 510(k)
    FDA Unclassified ·Unknown

    J.M. MURRAY CENTER, INC.

    FDA registration
    J.M. MURRAY CENTER, INC.·4 products·🇺🇸 United States

    MEDEN-INMED, SP. Z O.O.

    FDA registration
    MEDEN-INMED, SP. Z O.O.·3 products·🇵🇱 Poland