1,018 results · 27ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC, ATLAS, EPIC II, AND ATLAS II ICD FAMILIES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODELS L15IU AND L16IU

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA Single-Piece Posterior Chamber Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune®

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS MODELS OF PACEMAKERS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER/FRONTIER II CRT-P

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert Intraocular Lenses (IOLs)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA Single-Piece Anterior Chamber Intraocular Lens

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSERT DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Patient Connector

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® 15 Defibrillator Lithium- ion Rechargeable Battery Accessory

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

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)