BEUDAMED
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    COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MAXIM VI KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304205451·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971413·

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    R&D CBC-XE HEMATOLOGY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·October 2, 2018

    RADIUS-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 2, 2015

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 25, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 14, 2023

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 14, 2023

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 14, 2023

    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