36 results
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60ms
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Sources: EU EUDAMED, US FDA
Truth Renew Plus
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Truth Renew
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Ultra Renew Plus
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Ultra Renew
FDA Enforcement
Class II
·Terminated·Accord Media, LLC·March 7, 2018
Truth Renew Plus
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Ultra Renew Plus
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Truth Renew
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
Ultra Renew
FDA Recall
Terminated
·Accord Media, LLC Apartment·Product code OLP·December 4, 2017
UNKNOWN ENDO GIA INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 12, 2020
MESH TSL - PERMACOL¿
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTM·April 1, 2020
UNKNOWN EEA
FDA Adverse Event
Injury
·US SURGICAL PUERTO RICO·Product code GDW·April 29, 2019
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·June 2, 2021
SHARKCORE
FDA Adverse Event
Injury
·COVIDIEN LP BARRX·Product code FCG·September 3, 2020
SIMPLEXA COVID-19 DIRECT ASSAY
FDA Adverse Event
Malfunction
·DIASORIN MOLECULAR LLC·Product code QJR·January 7, 2022
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·January 10, 2019
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·January 10, 2019
UNKNOWN EGIA TRI STAPLE
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·June 2, 2021
UNKNOWN PARIETEX PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·June 26, 2019
UNKNOWN TRI STAPLE PRODUCT
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 11, 2020
UNKNOWN PROTACK
FDA Adverse Event
Death
·US SURGICAL PUERTO RICO·Product code GDW·July 3, 2019