BEUDAMED
    86 results · 72ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    COBAS® 4800 BRAF V600 MUTATION TEST

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·May 24, 2024

    CT EXPRES

    FDA Adverse Event
    Injury ·BRACCO INJENEERING S.A.·Product code IZQ·April 21, 2026

    SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC·Product code OBJ·February 21, 2020

    ID NOW COVID 19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 27, 2021

    SPY FLUORESCENCE IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·NOVADAQ TECHNOLOGIES INC.·Product code IZI·February 3, 2017

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·May 21, 2018

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·May 21, 2018

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·May 21, 2018

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·May 21, 2018

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·May 21, 2018

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 8, 2025

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·July 16, 2018

    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    EXPANSE LABORATORY / GENETICS / MICROBIOLOGY AND ANATOMICAL PATHOLOGY

    FDA Adverse Event
    Injury ·MEDICAL INFORMATION TECHNOLOGY, INC.·Product code JQP·October 27, 2025

    ION

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code EOQ·February 15, 2024

    PROTOCOL TOUCH ADMINISTRATION SET

    FDA Adverse Event
    Injury ·BRACCO DIAGNOSTIC INC·Product code FCX·June 28, 2019

    PROTOCOL TOUCH ADMINISTRATION SET

    FDA Adverse Event
    Injury ·BRACCO DIAGNOSTICS INC·Product code FCX·June 28, 2019

    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·January 14, 2015

    NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010