BEUDAMED
    5 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    FDA Enforcement
    Class II ·Ongoing·Hycor Biomedical Inc·August 14, 2019

    Heron toilet and bath chair Model 880505-01 & 880505-11

    FDA Enforcement
    Class II ·Ongoing·R82 A/S·November 21, 2018

    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

    FDA Enforcement
    Class II ·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023

    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·May 22, 2024

    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

    FDA Enforcement
    Class II ·Ongoing·THOR Photomedicine Ltd·February 7, 2024