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

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SWEET TIP RX STEROID ELUTING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS

Replacement Heart-Valve

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process

Replacement Heart-Valve

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP

Replacement Heart-Valve

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

Permanent Pacemaker Electrode

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS

Replacement Heart-Valve

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

Permanent Pacemaker Electrode

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CARBON TIPPED LEAD ALT.PROD.TRAYS

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MYOCARDIAL PACING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P