BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 2, 2016

    LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·March 16, 2016

    LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·March 16, 2016

    LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·March 16, 2016

    Bio-PLASTY Cannula (Needle)

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    Bio-CORE Cannula (Needle) Set

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    Bio-MAC Cannula (Needle) Set

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·March 14, 2018

    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Monterrey)·June 3, 2020

    Extra corporeal circuit with bio-active surface.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·July 15, 2020

    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

    FDA Enforcement
    Class II ·Terminated·Signal Medical Corporation·April 26, 2017

    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015

    Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·May 17, 2017

    Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·May 17, 2017

    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018