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

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

    Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 21, 2018

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·December 7, 2016

    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 15, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy. .

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 19, 2016

    Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 19, 2016