6 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA Enforcement
Class II
·Ongoing·DeVilbiss Healthcare LLC·May 10, 2023
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
FDA Enforcement
Class II
·Ongoing·DeVilbiss Healthcare LLC·December 28, 2022
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
FDA Enforcement
Class II
·Terminated·DeVilbiss Healthcare LLC·October 9, 2013
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014
DeVilbiss Model 7305P-D Powered Suction Unit
FDA Enforcement
Class II
·Terminated·DeVilbiss Healthcare LLC·July 27, 2016
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
FDA Enforcement
Class II
·Ongoing·DeVilbiss Healthcare LLC·November 23, 2022