BEUDAMED
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    Millipede 088 Access Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370142·The Millipede 088 Access Catheter consists of t...

    Aspiration Tube Set

    FDA UDI
    PERFUZE LIMITED·05391539370074·The Perfuze Aspiration Tube Set is a sterile, s...

    Millipede 088 Access Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370005·The Millipede 088 Access Catheter consists of t...

    Zipline 088 Access Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370067·The Zipline 088 Access Catheter is a single-use...

    Millipede 088 Access Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370111·The Millipede 088 Access Catheter consists of t...

    Zipline 070 Access Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370050·The Zipline 070 Access Catheter is a single-use...

    Millipede70 Aspiration Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370241·The Millipede70 Aspiration Catheter is a steril...

    Millipede 070 Aspiration Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370180·The Millipede 070 Aspiration Catheter is a ster...

    Millipede 088 Access Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370197·The Millipede 088 Access Catheter consists of t...

    Millipede 070 Aspiration Catheter

    FDA UDI
    PERFUZE LIMITED·05391539370098·The Millipede 070 Aspiration Catheter is a ster...

    ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Enforcement
    Class II ·Terminated·Volcano Corp·July 15, 2015

    Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Enforcement
    Class II ·Terminated·Volcano Corp·July 15, 2015

    Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Enforcement
    Class II ·Terminated·Volcano Corp·July 15, 2015

    Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·September 19, 2012

    Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·November 6, 2013

    Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.

    FDA Recall
    Terminated ·Vital Images, Inc.·Product code LLZ·March 15, 2013

    Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·August 12, 2009

    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.

    FDA Enforcement
    Class II ·Terminated·LABORIE MEDICAL TECHNOLOGIES, CANADA ULC·July 15, 2020

    ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Recall
    Terminated ·Volcano Corp·Product code IYO·September 23, 2013

    Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Recall
    Terminated ·Volcano Corp·Product code IYO·September 23, 2013