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

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·PMA NIT-OCCLUD PDA

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS CORNEAL IMPLANTS

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS CORNEAL IMPLANTS

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON - TB

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P

Replacement Heart-Valve

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

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 BIOPROSTHESIS, MODELS 2625

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

FPC/SFPC/RFPC ACETABULAR COMPONENT

FDA 510(k)
FDA Class 3 ·Orthopedic

CPS ACETABULAR COMPONENT

FDA 510(k)
FDA Class 3 ·Orthopedic

Replacement Heart-Valve

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

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 BIOPROSTHESIS,MODELS 2625 & 6625