7 results
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8ms
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Sources: EU EUDAMED, US FDA
Multichem P, Part Code 08P90-10
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Enforcement
Class II
·Terminated·Aerogen Ltd.·October 29, 2014
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023