3,158 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NANO-CIC-RECHARGE-JH-R/B
FDA Adverse Event
Injury
·NANO HEARING TECH OPCO, LLC·Product code QUF·December 30, 2022
DRIVE
FDA Adverse Event
Injury
·JHR ELECTRIC TRANSPORTS, LLC·Product code INI·July 12, 2022
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
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·September 16, 2015
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·November 11, 2025
ELECSYS IGE II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·May 15, 2024
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·April 9, 2024
ELECSYS IGE II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·August 7, 2023
ELECSYS IGE II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·July 20, 2023
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·April 12, 2023
IMMUNOGLOBULIN E
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·January 26, 2016
IMMUNOGLOBULIN E
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·March 29, 2016
ELECSYS IGE II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·April 21, 2025
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·March 28, 2018
ELECSYS IGE II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·October 6, 2023
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·June 1, 2017
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·May 9, 2018
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·February 3, 2015
IMMUNOGLOBULIN E
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·February 24, 2015
ELECSYS IGE II IMMUNOASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JHR·January 9, 2015