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    SIGNA PET/MR

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111299278·TC SKLHN KILNER SCISS CVD 5"

    SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FLIPPER DETACHABLE EMBOLIZATION COILS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code KRD·January 2, 2017

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code KRD·June 13, 2018

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code KRD·March 8, 2017

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 20, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 7, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 28, 2018

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code KRD·March 8, 2017

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 12, 2018

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 11, 2013

    STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.

    FDA Adverse Event
    Malfunction ·FRESENIUS REYNOSA MANUFACTURING·Product code KDJ·July 17, 2014

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·July 15, 2011

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code KRD·February 7, 2017

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code KRD·February 21, 2017