BEUDAMED
    131 results · 8ms · Sources: EU EUDAMED, US FDA

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

    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

    FDA Enforcement
    Class II ·Completed·Sysmex America, Inc.·November 1, 2017

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Enforcement
    Class II ·Completed·Materialise USA LLC·August 31, 2022

    Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

    FDA Enforcement
    Class II ·Completed·ESAOTE S.P.A.·March 11, 2026

    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Discovery NM/CT 670 Pro, model 5376204-70-54

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

    FDA Enforcement
    Class II ·Completed·Acumed LLC·April 27, 2022

    Discovery NM/CT 670 ES, model 5376204-70-57

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

    FDA Enforcement
    Class II ·Completed·Acumed LLC·April 27, 2022

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

    FDA Enforcement
    Class II ·Completed·Landauer·January 3, 2024

    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

    FDA Enforcement
    Class II ·Completed·Fresenius Kabi USA, LLC·March 20, 2024

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.

    FDA Enforcement
    Class II ·Completed·Alere San Diego, Inc.·February 7, 2018

    Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.

    FDA Enforcement
    Class II ·Completed·Alliance Tech Medical, Inc·December 25, 2019

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Completed·Hycor Biomedical Inc·August 7, 2019

    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021