8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Standalone ALIF Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
MOIST PUNCTAL PLUG SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
NAVIOPFS
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
PLUS SL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·November 5, 2008
IN TOUCH ZX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 17, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 5, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025