BEUDAMED
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    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·September 30, 2015

    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code GKZ·August 27, 2015

    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·April 26, 2018

    Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·October 25, 2010

    Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Draeger Medical, Inc.·June 6, 2018

    Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·January 5, 2011

    Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·September 1, 2010

    Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·September 19, 2007

    Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·March 9, 2011

    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    FDA Recall
    Terminated ·GE Healthcare·Product code FMT·April 2, 2014

    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·May 14, 2014

    Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.

    FDA Recall
    Terminated ·Advanced Orthogonal Equipment, Incorporated·Product code LXM·March 6, 2013

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·January 7, 2015

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 18, 2015

    Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.

    FDA Enforcement
    Class II ·Terminated·Advanced Orthogonal Equipment, Incorporated·July 31, 2013

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012

    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 Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 17, 2012

    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

    Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code KQM·March 18, 2013