322 results · 17ms · Sources: EU EUDAMED, US FDA

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 (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

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

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 Extended Tips accessory; PROGEL 11 Extende

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·LifeStream® Balloon Expandable Vascular Covered Stent

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·iCast Covered Stent System

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis