483 results · 22ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-PMMA PCL'S

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

Intraocular Lens

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

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel Pleural Air Leak Sealant (Progel™ PALS)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Tridyne Vascular Sealant

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel Pleural Air Leak Sealant

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Aaris intraocular lens model EC-3 and EC-3 PAL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT LUCIA 202 IOL and CT LUCIA 602 IOL

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory