982 results · 18ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·FINELINE II STEROX LEADS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CYLOS FAMILY OF PULSE GENERATORS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Permanent Pacemaker Electrode

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

Permanent Pacemaker Electrode

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SOLOX VDD PACING LEAD

Permanent Pacemaker Electrode

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Porcine 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 SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND

Permanent Pacemaker Electrode

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE PACEMAKER LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL SDX

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE(R) MODEL 5023M,5024M PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS