BEUDAMED
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    HALYARD

    FDA Adverse Event
    Malfunction ·LA ADA DE ACUNA, S. DE. R. L. DE C. V.·Product code PUI·May 21, 2019

    HALYARD

    FDA Adverse Event
    Malfunction ·LA ADA DE ACUNA, S. DE. R. L. DE C. V.·Product code PUI·May 21, 2019

    HALYARD

    FDA Adverse Event
    Malfunction ·LA ADA DE ACUNA, S. DE. R. L. DE C. V.·Product code PUI·May 21, 2019

    HALYARD

    FDA Adverse Event
    Malfunction ·LA ADA DE ACUNA, S. DE. R. L. DE C. V.·Product code PUI·May 21, 2019

    HALYARD

    FDA Adverse Event
    Malfunction ·LA ADA DE ACUNA, S. DE. R. L. DE C. V.·Product code PUI·July 5, 2019

    HALYARD

    FDA Adverse Event
    Malfunction ·LA ADA DE ACUNA, S. DE. R. L. DE C. V.·Product code PUI·July 5, 2019

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    CRITIKON SOFT-CUFF

    FDA Adverse Event
    Injury ·GENERAL ELECTRIC CO / CRITIKON DE MEXICO S. DE R. L. DE C.V.·Product code DXQ·October 10, 2018

    Radioimmunoassay, Total Thyroxine

    FDA classification
    FDA Class 2 ·Radioimmunoassay, Total Thyroxine

    Plasminogen, Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Plasminogen, Antigen, Antiserum, Control

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·July 30, 2014

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·November 13, 2013

    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

    FDA Enforcement
    Class II ·Terminated·Advance Dx, Inc.·August 18, 2021

    ROSA One 3.1 Brain Application

    FDA Recall
    Terminated ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020

    ROSA Brain 3.0 Application-Brain

    FDA Recall
    Terminated ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·January 6, 2020

    Ldt, Approved By Nys Clep

    FDA classification
    FDA Not Classified ·Ldt, Approved By Nys Clep

    Ldl & Vldl Precipitation, Hdl

    FDA classification
    FDA Class 1 ·Ldl & Vldl Precipitation, Hdl

    Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule