BEUDAMED
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    Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·November 13, 2023

    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No

    FDA Recall
    Open, Classified ·Thoratec LLC·Product code DSQ·May 13, 2026

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·April 24, 2026

    TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929

    FDA Recall
    Open, Classified ·Full Vision Inc·Product code IOL·May 12, 2023

    HAMILTON-C6, REF: 160021

    FDA Recall
    Open, Classified ·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·March 14, 2023

    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·December 9, 2022

    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FMG·August 1, 2022

    8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPD·August 1, 2022

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code PFQ·March 5, 2024

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code PFQ·March 5, 2024

    6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022