BEUDAMED
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    U-Lite EXP

    FDA 510(k)
    FDA Class 2 ·Radiology

    JYV CONCEPT

    Importer
    🇫🇷 France·2 Manufacturers

    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·February 10, 2016

    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·April 30, 2014

    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·August 20, 2014

    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    FDA Enforcement
    Class II ·Ongoing·Imactis·January 29, 2020

    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A

    FDA Enforcement
    Class II ·Ongoing·B.Braun Medical S.A.S.·September 17, 2025

    I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

    FDA Enforcement
    Class II ·Ongoing·In2Bones, SAS·March 27, 2024

    I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

    FDA Enforcement
    Class II ·Ongoing·In2Bones, SAS·March 27, 2024

    NucliSENS Lysis Buffer Extended lot for RES 76675

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·November 15, 2017

    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    FDA Enforcement
    Class II ·Terminated·Perouse Medical·July 30, 2014

    ETABLISSEMENT DELATEX

    Importer
    🇫🇷 France·14 Manufacturers