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

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Plasmaflo™ OP-05W(A)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Prismaflex TPE2000 Set

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Prismaflex TPE2000 Set

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PRISMA TPE 2000 SET

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Gambro Prismaflex TPE 2000 Set

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VISIA AF VR, VISIA AF MRI VR SURESCAN, EVERA S DR ICD, EVERA S VR ICD,EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, P

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification
FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification
FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification
FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer