7 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·January 31, 2018
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
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer.
FDA Enforcement
Class II
·Terminated·Alere San Diego, Inc.·September 11, 2019
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
FDA Enforcement
Class II
·Terminated·Accriva Diagnostics Inc., dba ITC, dba Accumetrics·June 1, 2016
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
FDA Enforcement
Class II
·Terminated·J T Posey Company·April 17, 2013