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    WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011

    PILLING

    FDA UDI
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    AIM™FEMORAL NAIL

    FDA UDI
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    OrthoMedFlex

    FDA UDI
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    FDA UDI
    Unisensor AG·07640172971239·

    ULTRACONCENTRATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEROGEL OTOLOGIC PACK

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRE·June 30, 2021

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRE·June 30, 2021

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC.·Product code DRE·January 8, 2018

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·February 15, 2022

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·November 6, 2017

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·December 15, 2017

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·November 29, 2017

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·October 5, 2018

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Death ·COOK VANDERGRIFT INC·Product code DRE·May 18, 2023

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·October 25, 2022

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·March 3, 2022

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code DRE·June 29, 2022