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

Lens, Intraocular, Accommodative

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF UV-ABSORBING SINGLE-PIECE PC IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF UV-ABSORBING MULTI-PIECE PC IOL

Lens, Intraocular, Accommodative

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx DownStream System

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx Downstream System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ORBASONE PAIN RELIEF SYSTEM