9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044204766·TEST TUBE 13X100MM 2-POS CAP
PROFILE 1320 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXFIN MODEL 2
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·November 4, 2014
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·July 15, 2011
RECLAIM PRX BDY CONE 24X75
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code KWA·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025