10,000 results
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105ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
FDA Enforcement
Class I
·Terminated·Western / Scott Fetzer Company·July 29, 2015
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·May 13, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·June 14, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 28, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 30, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·June 25, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·June 28, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·November 29, 2021
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 6, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 11, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·May 4, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 12, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 19, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 8, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·June 2, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 28, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·May 4, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·April 12, 2022
ECHELON 60MM REINFORCEMENT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code OXC·May 3, 2022