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

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    CPX Control Breast Tissue Expander

    FDA 510(k)
    FDA Unclassified ·Unknown

    CONGRUENT BONE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REFSTAR RMT EXTERNAL REFERENCE PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 31, 2019

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    EX-PRESS MINI GLAUCOMA SHUNT

    FDA Adverse Event
    Injury ·OPTONOL, LTD·Product code KYF·May 30, 2013

    IDENTITY ADX SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    ARTICUL/EZE BALL 32 +13 BLK

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 23, 2011

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CANCELLOUS

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    SCREW, CORTICAL

    FDA Adverse Event
    Injury ·ARTHREX INC.·Product code HRS·November 7, 2017

    Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·August 23, 2017

    Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·May 11, 2017