BEUDAMED
    29 results · 27ms · Sources: EU EUDAMED, US FDA

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    Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative t the inner shaft.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·January 1, 2020

    Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·January 16, 2019

    Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·January 1, 2020

    S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The SMART Control stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The stent is equipped with 12 tantalum markers, 6 at each end, to increase the visibility of the stent under fluoroscopic imaging. The SMART Control stent system is designed to be delivered through an appropriately sized catheter sheath introducer.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·January 1, 2020

    Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 3, 2020

    B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 3, 2020

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

    Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 3, 2020

    Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 3, 2020

    Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 3, 2020

    Kangaroo 924 Safety Screw Spike Set, Product Code 775759

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 3, 2020

    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021

    FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021

    ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021

    DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021

    VAPORIZER VICKS 1.5GAL Item Number: 2354942

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021

    ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021

    ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health Inc.·June 30, 2021