BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    Achilles Express Bone Sonometer

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUA·September 3, 2019

    Achilles Insight Bone Sonometer

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUA·September 3, 2019

    Toshiba DUA-450F Kalare Radiographic Tilting Table.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IXR·July 15, 2010

    X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code QLT·November 8, 2021

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·January 12, 2022

    ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LTJ·August 9, 2016

    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

    FDA Recall
    Terminated ·Alung Technologies Inc·Product code QLN·December 18, 2020

    ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

    FDA Enforcement
    Class II ·Terminated·Alung Technologies Inc·February 10, 2021

    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 Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 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

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·September 23, 2022

    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code QLT·July 15, 2020

    LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·January 11, 2021

    Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003

    Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.

    FDA Recall
    Terminated ·Danatech Medical Systems Inc·Product code MAA·December 5, 2003

    Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003

    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·September 16, 2020

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Enforcement
    Class III ·Terminated·LumiraDx·November 2, 2022

    LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.

    FDA Enforcement
    Class II ·Terminated·LumiraDx·February 24, 2021