8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021826·OPTYC MBT ANT -6T 0A 018 LO
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
FDA 510(k)
FDA Class 2
·Microbiology
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·September 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022