20 results
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23ms
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Sources: EU EUDAMED, US FDA
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
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
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
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
FDA Enforcement
Class II
·Terminated·AccessClosure, Inc., A Cardinal Health Company·August 10, 2016
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
FDA Enforcement
Class II
·Terminated·AccessClosure, Inc., A Cardinal Health Company·November 2, 2016
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex Unit Dose 15 ml Normal Saline ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Medline Prefilled 550 ml Sterile¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
FDA Enforcement
Class II
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·November 28, 2018