7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OviTex PRS (Long-Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DynaFuse Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
NuVasive(R) CCX-L Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·November 11, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 12, 2011
PROMUS ELEMENT ?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025