10,000 results · 42ms · Sources: EU EUDAMED, US FDA

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Monorail® Premounted Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Cordis PRECISE Nitinol Stent System

Intraocular Lens

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

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC -L TOTAL DISC REPLACEMENT DEVICE

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

FDA Pre-Market Approval
FDA Class 3 ·LSC TOTAL KNEE SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC CUBES AND GRANULES

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval
FDA Class 3 ·POLYTEF PASTE FOR INJECTION

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCULAR SOLUTIONS DUETT SEALING DEVICE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Genesys HTA System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Exact System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MynxGrip Vascular Closure Device

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune System

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·Oxford® Partial Knee System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE