982 results · 19ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FAMILY OF LEADS/ACCESSORIES

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD

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 PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Myocardial Pacing Lead

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SP NOVUS MODEL 5092 (AND VITATRON EXCELLENCE SS+ MODEL IML 49B)

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MDX SILICONE TUBING

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis and Hancock II Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SENSE LEAD MODELS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL/PASSIVE PLUS/AV PLUS DX

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SELUTE, SELUTE PICOTIP

Replacement Heart-Valve

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC BIOPROSTHESIS MODELS 305 AND 310

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX (R)