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    CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GALILEO CAS/NAV TKR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·January 8, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    COLLAMEND

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTM·June 1, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 31, 2012

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·August 14, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRB·August 23, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·August 23, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·March 13, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·November 8, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DQX·October 25, 2024

    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

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRB·September 14, 2018

    HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. K130584 (Monitor B40): The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/ Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy. Product Quantity Distributed (Int) 16,061 (343 US, 15,718 OUS)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·October 11, 2013