7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Knee FiberTak® Button Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
HANAROSTENT Benefit Biliary (NNN)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 6, 2014
NUVASIVE LATERAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·July 22, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025