BEUDAMED
    17 results · 25ms · 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.
    Filters Regulation: Us FDA ×

    Quantib Brain 1.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613123536·Instrument Guards, Tinted Green, Vented Holes, ...

    ENDOSCOPIC INTRODUCER

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

    PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WAVEWRITER ALPHA? PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 21, 2025

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 11, 2013

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CIG·July 15, 2011

    EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 22, 2024

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

    OHICHO3

    FDA Adverse Event
    Injury ·Product code LIT·July 19, 2019

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 14, 2020

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 30, 2020

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 28, 2020

    OHICHO3

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 26, 2018

    OHICHO3

    FDA Adverse Event
    Injury ·Product code LIT·September 17, 2019

    Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·August 16, 2013