BEUDAMED
    9 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 5, 2014

    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 5, 2014

    ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·November 5, 2014

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    FDA Enforcement
    Class II ·Terminated·Epocal·August 21, 2013

    Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 15, 2013

    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 15, 2016