25 results
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63ms
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Sources: EU EUDAMED, US FDA
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pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·March 5, 2014
pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·January 22, 2014
TCM CombiM Modules 903-111
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·May 11, 2016
Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·March 25, 2015
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 15, 2012
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 15, 2012
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·October 10, 2018
ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·January 29, 2014
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·October 9, 2013
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·December 31, 2014
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 26, 2015
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 15, 2012
ABL800 analyzer, model numbers 393-800 and 393-801.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·January 2, 2019
Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·February 13, 2019
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·February 11, 2015
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 14, 2013
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·February 10, 2016
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·March 22, 2017
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·October 11, 2017
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·September 17, 2014