7,153 results · 22ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·O2OPTIX, AIR OPTRIX AQUA, AIR OPTIX FOR ASTIGMATISM ; AIR OPTIX AQUA MULTIFOCAL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit® PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON B SOFT CONTACT LENSES O2OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL.

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Air Optix Aqua, Air Optix Plus HydraGlyde Soft Contact Lenses

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic D-Light C PDD System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Muscular VSD Occluder

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta and Trifecta GT surgical Heart Valve

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Septal Occluder and Amplatzer Cribriform Occluder