991 results · 21ms · Sources: EU EUDAMED, US FDA

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ISERT GEMETRIC

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IPure Preloaded IOL System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN GEL

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS CL Foldable Silicone Intraocular Lens

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