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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HR HPV Assay

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV Assay

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA INTRAOCULAR LENSES (IOLS)

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA INTRAOCULAR LENSES (IOLS)

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

FDA Pre-Market Approval
FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integra Dermal Regeneration Template

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM

Heart-Valve, Non-Allograft Tissue

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

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA/SYNCRA CRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PROTECTA DR/VR/XT DR/XT VR