BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    Pure Flow External Counter-Pulsation Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INGENUITY TF PET/MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAPPHIRE O/E ORAL EXAMINATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code MND·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

    SST FIBULA NAIL

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code HSB·September 25, 2008

    BD FACSCALIBUR FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 20, 2023

    BD FACSCALIBUR¿ FLOW CYTOMETER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

    NV EHXL ALIP LNR G4 36MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 18, 2022

    Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code OUO·April 13, 2012