36 results · 60ms · Sources: EU EUDAMED, US FDA

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Truth Renew Plus

FDA Enforcement
Class II ·Terminated·Accord Media, LLC·March 7, 2018

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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

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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

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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