4 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
FDA Enforcement
Class II
·Ongoing·Ohio Medical Corporation·June 25, 2025
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
FDA Enforcement
Class II
·Terminated·Ohio Medical Corporation·July 18, 2018
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
FDA Enforcement
Class II
·Terminated·Ohio Medical Corporation·September 19, 2018
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
FDA Enforcement
Class II
·Ongoing·Ohio Medical Corporation·January 19, 2022