BEUDAMED
    34 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·November 13, 2019

    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200

    FDA Enforcement
    Class III ·Ongoing·Becton Dickinson & Company·March 2, 2022

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·May 9, 2018

    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·November 2, 2016

    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·November 2, 2016

    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Company·August 26, 2015

    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·July 23, 2014

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·July 10, 2013

    BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Company·March 13, 2013

    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·May 3, 2017

    BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Company·April 10, 2013

    BD MAX DNA MMK Lab Use, catalog no. 442828

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·May 9, 2018

    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·December 13, 2017

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    FDA Enforcement
    Class III ·Ongoing·Bausch & Lomb Surgical, Inc.·September 3, 2025

    FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

    FDA Enforcement
    Class III ·Ongoing·Owens & Minor Distribution, Inc.·February 15, 2023

    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

    FDA Enforcement
    Class III ·Terminated·R & D Systems, Inc.·November 14, 2018

    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

    FDA Enforcement
    Class III ·Terminated·BD Biosciences, Systems & Reagents·July 22, 2015

    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

    FDA Enforcement
    Class III ·Terminated·BD Biosciences, Systems & Reagents·August 20, 2014

    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 Enforcement
    Class III ·Terminated·R & D Systems, Inc.·January 9, 2019