5 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Recall
Terminated
·Alere San Diego, Inc.·Product code JJE·February 15, 2019
BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DQA·February 27, 2008
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code: 100/134/030. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
FDA Recall
Terminated
·Remington Medical Inc.·Product code DSA·March 5, 2014