Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·Xvivo Perfusion System (XPS) with Steen Solution Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XPS with Steen Solution Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System with STEEN Solution Perfusate

LIFE SUPPORT FOR TRAUMA AND TRANSPORT

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Artificial Pancreas Device System, Threshold Suspend

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Sensor-Enabled Pump System-Continuous Glucose Monitoring System

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM-ADDITION OF ROTATING PLATFORM TIBIAL TRAY WITH KEEL

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

FDA Pre-Market Approval

FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM