1,156 results · 39ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920)

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Liver

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Mesh, Surgical, Polymeric

FDA Pre-Market Approval
FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval
FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval
FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval
FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT

Mesh, Surgical, Polymeric

FDA Pre-Market Approval
FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR

Intraocular Lens

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·HYDRO MARC LENSES (HYDROPHILIC)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CORDIS EUROPASS PTCA DILATATION CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CORDIS PREDATOR PTCA DILITATION CATHETER