23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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bellavista 1000
FDA 510(k)
FDA Class 2
·Anesthesiology
ENTEROCOCCUS FAECALIS PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
SOMATOM DEFINITION AS
FDA 510(k)
FDA Class 2
·Radiology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·January 3, 2006
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 15, 2011
EEA 33MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·September 16, 2008
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·March 24, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·February 20, 2014
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·May 17, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
RESOLUTE ONYX RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·January 7, 2025
RESOLUTE ONYX RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·January 7, 2025
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·June 5, 2020
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 12, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·March 18, 2019
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·November 4, 2022
OPTILITE SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 13, 2020
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014