BEUDAMED
    20 results · 6ms · Sources: EU EUDAMED, US FDA

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

    Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

    FDA Enforcement
    Class II ·Terminated·Animas Corporation·November 5, 2014

    Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

    FDA Enforcement
    Class II ·Terminated·Dexcom Inc·February 12, 2020

    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053

    FDA Enforcement
    Class II ·Terminated·Medtronic·June 21, 2017

    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 16, 2016

    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 16, 2016

    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is 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·March 16, 2016

    BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·June 9, 2021

    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry System is 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·March 16, 2016

    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·July 9, 2014

    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·February 5, 2014

    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·March 12, 2014

    WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies

    FDA Enforcement
    Class II ·Terminated·Bigwall Enterprises·March 2, 2016

    Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)

    FDA Enforcement
    Class II ·Terminated·Versea Diagnostics LLC·September 8, 2021

    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

    FDA Enforcement
    Class II ·Terminated·Alere Scarborough, Inc. dba Binax, Inc.·July 22, 2015

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 16, 2016