BEUDAMED
    23 results · 18ms · Sources: EU EUDAMED, US FDA

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

    4205 Journey Rolling Walker Product Usage: used to assist people in walking

    FDA Enforcement
    Class II ·Terminated·Nova Ortho-Med Inc·November 2, 2016

    FPS 35mm x 3.5 mm non-locking screw

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·September 28, 2016

    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·October 14, 2015

    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·August 9, 2017

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    FDA Enforcement
    Class II ·Terminated·Ortho Organizers, Inc.·July 8, 2020

    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

    FDA Enforcement
    Class II ·Terminated·Ortho Organizers, Inc.·July 8, 2020

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 1, 2020

    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·February 19, 2020

    7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 1, 2020

    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·January 13, 2021

    enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·January 13, 2021

    Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·February 27, 2019

    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020

    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020

    VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·March 24, 2021

    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·October 27, 2021

    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 20, 2021

    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 20, 2021

    VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. . For emergency authorization use only (EAU). Intended for Use in the United States Product Code: 6199949.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·March 24, 2021

    VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·March 31, 2021