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    EUROIMMUN LYME ELISA(IgG/IgM)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694043786·2.0mm 6 Hole Straight Locking Plate, 2.0mm thick

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·March 31, 2016

    MTF ALLOGRAFT ANCHOR

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

    BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    AU2700 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMAK.K.·Product code JGS·June 28, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    BD ARTERIAL CANNULA 20G/45 MM

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 25, 2015

    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

    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-71350-25V17 FA-71400-25V11 FA-71425-35V15 FA-71475-30V18 FA-71300-25V13 FA-71350-25V18 FA-71400-25V12 FA-71425-35V18 FA-71475-35V09 FA-71300-25V15 FA-71350-25V19 FA-71400-25V13 FA-71450-25V09 FA-71475-35V10 FA-71300-25V16 FA-71350-30V09 FA-71400-25V15 FA-71450-25V10 FA-71475-35V11 FA-71300-25V17 FA-71350-30V10 FA-71400-25V16 FA-71450-25V11 FA-71475-35V12 FA-71300-25V18 FA-71350-30V12 FA-71400-25V18 FA-71450-25V12 FA-71475-35V13 FA-71300-25V19 FA-71350-30V13 FA-71400-25V19 FA-71450-25V13 FA-71475-35V15 FA-71300-30V09 FA-71350-30V15 FA-71400-30V09 FA-71450-25V15 FA-71475-35V18 FA-71300-30V12 FA-71350-30V16 FA-71400-30V10 FA-71450-25V16 FA-71475-35V19 FA-71300-30V13 FA-71350-30V18 FA-71400-30V11 FA-71450-25V18 FA-71500-25V09 FA-71300-30V15 FA-71350-35V09 FA-71400-30V12 FA-71450-25V19 FA-71500-25V10 FA-71300-30V16 FA-71350-35V10 FA-71400-30V13 FA-71450-30V09 FA-71500-25V11 FA-71300-30V19 FA-71350-35V12 FA-71400-30V15 FA-71450-30V10 FA-71500-25V12 FA-71300-35V09 FA-71350-35V13 FA-71400-30V16 FA-71450-30V11 FA-71500-25V13 FA-71300-35V12 FA-71350-35V15 FA-71400-30V18 FA-71450-30V12 FA-71500-25V15 FA-71300-35V13 FA-71350-35V18 FA-71400-35V09 FA-71450-30V13 FA-71500-25V16 FA-71300-35V15 FA-71375-25V09 FA-71400-35V13 FA-71450-30V15 FA-71500-25V18 FA-71325-25V09 FA-71375-25V10 FA-71400-35V15 FA-71450-30V16 FA-71500-25V19 FA-71325-25V10 FA-71375-25V11 FA-71400-35V18 FA-71450-30V18 FA-71500-30V09 FA-71325-25V12 FA-71375-25V12 FA-71425-25V09 FA-71450-30V19 FA-71500-30V10 FA-71325-25V13 FA-71375-25V13 FA-71425-25V10 FA-71450-35V09 FA-71500-30V11 FA-71325-25V15 FA-71375-25V15 FA-71425-25V11 FA-71450-35V10 FA-71500-30V12 FA-71325-25V18 FA-71375-25V16 FA-71425-25V12 FA-71450-35V12 FA-71500-30V13 FA-71325-25V19 FA-71375-25V17 FA-71425-25V13 FA-71450-35V13 FA-71500-30V15 FA-71325-30V09 FA-71375-25V18 FA-71425-25V15 FA-71450-35V15 FA-71500-30V16 FA-71325-30V10 FA-71375-25V19 FA-71425-25V16 FA-71450-35V16 FA-71500-30V17 FA-71325-30V12 FA-71375-30V09 FA-71425-25V18 FA-71475-25V09 FA-71500-30V18 FA-71325-30V13 FA-71375-30V10 FA-71425-25V19 FA-71475-25V10 FA-71500-35V09 FA-71325-30V15 FA-71375-30V12 FA-71425-30V09 FA-71475-25V11 FA-71500-35V10 FA-71325-30V16 FA-71375-30V13 FA-71425-30V10 FA-71475-25V12 FA-71500-35V11 FA-71325-30V18 FA-71375-30V15 FA-71425-30V11 FA-71475-25V13 FA-71500-35V12 FA-71325-30V19 FA-71375-30V16 FA-71425-30V12 FA-71475-25V15 FA-71500-35V13 FA-71325-35V09 FA-71375-30V18 FA-71425-30V13 FA-71475-25V16 FA-71500-35V15 FA-71325-35V12 FA-71325-35V13 FA-71325-35V15 FA-71350-25V09 FA-71350-25V10 FA-71350-25V13 FA-71350-25V15 FA-77250-10V13 FA-77250-10V19 FA-77250-12V11 FA-77250-12V12 FA-77250-12V13 FA-77250-12V18 FA-77250-14V12 FA-77250-14V13 FA-77250-14V15 FA-77250-14V18 FA-77250-14V19 FA-77250-16V11 FA-77250-16V12 FA-77250-16V13 FA-77250-16V15 FA-77250-16V16 FA-77250-16V19 FA-77250-18V09 FA-77250-18V10 FA-77250-18V11 FA-77250-18V12 FA-77250-18V13 FA-77250-18V16 FA-77250-18V18 FA-77250-18V19 FA-77250-20V10 FA-77250-20V11 FA-71375-35V09 FA-71375-35V12 FA-71375-35V13 FA-71375-35V15 FA-71375-35V16 FA-71375-35V18 FA-71400-25V09 FA-77275-14V11 FA-77275-14V12 FA-77275-14V13 FA-77275-14V17 FA-77275-14V18 FA-77275-14V19 FA-77275-16V12 FA-77275-16V13 FA-77275-16V16 FA-77275-16V18 FA-77275-16V19 FA-772

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016