9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aniti-Snore Mouthguard+
FDA 510(k)
FDA Class 2
·Dental
Sklar®
FDA UDI
SKLAR CORPORATION·10649111144561·SKLARLITEXD OP SCISS SS CV51/2
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
RESPIRE PINK SERIES - HERBST
FDA 510(k)
FDA Class 2
·Dental
AMSure® Single Use Saline Topical Solution
FDA 510(k)
FDA Unclassified
·Unknown
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
PLUM A+ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 30, 2008
CORONARY CUSTOM PACK
FDA Adverse Event
Malfunction
·AVID MEDICAL, INC.·Product code KDD·June 26, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·August 26, 2011