5 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·January 14, 2014
THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 26, 2014
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)