12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PixoTest Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO MODEL 750 SERIES MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COVAMAX RESORBABLE COLLAGEN MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 15, 2008
EEA 25MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·April 26, 2016
EEA 25MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·April 26, 2016
EEA 25MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·April 26, 2016
EEA 25MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·April 26, 2016
EEA 25MM SINGLE-USE STAPLER
FDA Adverse Event
Death
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·April 26, 2016