982 results · 20ms · Sources: EU EUDAMED, US FDA

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE/CAPSURESP/NOVUS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Porcine Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODELS CAPSURE SP 5023M, CAPSURE SP 5524M AND CAPSURE Z 5033

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CAPSURE SP MODEL 5024M

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·THINLINE II/ FINELINE II

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·HOME MONITORING SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP