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

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    DIODE LASER

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

    KALAZAR DETECT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INGENUITY TF PET/MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MO.MA. ULTRA 6F ID

    FDA Adverse Event
    Malfunction ·INVATEC SPA·Product code NTE·May 22, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    PY2 PACING LEAD

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DTB·June 7, 2011

    TRIATHLON P/A CR BEADED #5L

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024

    TRIATHION

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024

    TRIATHION COMPONENT

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024

    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