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

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

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

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Multiple Use Blood Lancet For Multiple Patient Use

FDA classification

FDA Class 3 ·Multiple Use Blood Lancet For Multiple Patient Use

Bone Grafting Material, Dental, With Biologic Component

FDA classification

FDA Class 3 ·Bone Grafting Material, Dental, With Biologic Component

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA classification

FDA Class 3 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Filler, Bone Void, Synthetic Peptide

FDA classification

FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

Test System, For Drugs Of Abuse

FDA classification

FDA Class 3 ·Test System, For Drugs Of Abuse

Tissue Graft Of Less Than 6mm

FDA classification

FDA Class 3 ·Tissue Graft Of Less Than 6mm

Extended Depth Of Focus Intraocular Lens

FDA classification

FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Tissue Graft Of 6mm And Greater

FDA classification

FDA Class 3 ·Tissue Graft Of 6mm And Greater

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device