474 results · 28ms · Sources: EU EUDAMED, US FDA

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·CONCEPTUS ESSURE SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INGEVITY Passive Fixation leads

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTABLE GEL

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion

Intraocular Lens

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis, Models 305 and 310

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MULTI-PIECE PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

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 ·Hancock Valved Conduit, Model 105

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof™ IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof™ Natural UV and Blue L

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Hancock Modified Orifice (MO) Valved Conduit, Model 150

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis, Model 995, 995SC and 995MS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE HBSAG, IMMULITE 2000 HBSAG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REPLY AND ESPIRIT FAMILY OF PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·KONECT RESILIA Aortic Valved Conduit (AVC)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx