BEUDAMED
    23 results · 25ms · Sources: EU EUDAMED, US FDA

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    HI-TORQUE VERSACORE GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTROID HEMORRHOID MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 26, 2026

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 10, 2014

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 29, 2013

    ENPULSE

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code DXY·May 10, 2011

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024

    880 HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023

    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

    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

    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