BEUDAMED
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    Filters FDA Enforcement × Status: Terminated × Clear all

    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

    FDA Enforcement
    Class II ·Terminated·Western / Scott Fetzer Company·July 2, 2014

    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    Ultrasonic Bronchoscope BF-UC160F-OL8

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 10, 2018

    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·December 9, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·December 9, 2020

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.

    FDA Enforcement
    Class III ·Terminated·Celera Corporation·September 4, 2013