3 results
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34ms
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Sources: EU EUDAMED, US FDA
CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac studies such as echocardiography or radionuclide ventriculography. - Antitachycardia pacing for cardioversion of supraventricular tachycardia (SVT), including atrial flutter and re-entrant atrial or atrioventricular paroxysmal tachycardia. - Esophageal electrocardiography for differential diagnosis of complex atrial arrhythmia
FDA Enforcement
Class III
·Terminated·Cardiocommand Inc.·June 19, 2019
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Enforcement
Class II
·Terminated·Accelerate Diagnostics Inc·May 2, 2018
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits.
FDA Enforcement
Class II
·Terminated·Accelerate Diagnostics Inc·April 3, 2019