BEUDAMED
    37 results · 7ms · Sources: EU EUDAMED, US FDA

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

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Procera LLC·June 2, 2021

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    FDA Enforcement
    Class II ·Terminated·Rocket Medical Plc·December 4, 2019

    Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·June 7, 2017

    PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014