11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Fiagon Navigation System
FDA 510(k)
FDA Class 2
·Neurology
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
FDA 510(k)
FDA Class 2
·Cardiovascular
RELIEF ACP ORAL CARE GEL
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·December 13, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 10, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 7, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020