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    APPS-HEALTH01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenZ HT+ 98x25 B2

    FDA UDI
    ARGEN CORPORATION, THE·D818122098·Dental porcelain/ceramic restoration kit

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TBD

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ONESTEP CPR (AA) ELECTRODES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·July 25, 2012

    ONESTEP CPR (AA) ELECTRODES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·July 25, 2012

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 9, 2015

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 9, 2015

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 30, 2026

    CPR STAT PADZ

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MLN·December 29, 2008

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 16, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 19, 2014

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·June 3, 2011

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MPB·February 13, 2017

    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

    UNI-VENT, MODEL 731

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code CBK·January 3, 2022

    UNI-VENT, MODEL 731

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code CBK·January 3, 2022

    UNI-VENT, MODEL 731

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code CBK·January 3, 2022

    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