154 results · 19ms · Sources: EU EUDAMED, US FDA

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

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

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE Silicon-Filled Breast Implants

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CSI CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CSI(CROFILCON A)EXTENDED WEAR SOFT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·8IGNATURE CONTACT LENS