Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA CP with Smart Assist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5

Prosthesis, Posterior Spinal Elements

FDA classification

FDA Class 3 ·Prosthesis, Posterior Spinal Elements

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA classification

FDA Class 3 ·Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval

FDA Class 3 ·Optune Lua

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval

FDA Class 3 ·Optune Lua

Pacemaker/Icd/Crt Non-Implanted Components

FDA classification

FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

Implantable Cardioverter Defibrillator (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-Crt)

Stimulator, Bone Growth, Non-Invasive

FDA classification

FDA Class 3 ·Stimulator, Bone Growth, Non-Invasive

Heart-Valve, Non-Allograft Tissue

FDA classification

FDA Class 3 ·Heart-Valve, Non-Allograft Tissue

Sensor, Glucose, Invasive, Non-Adjunctive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA classification

FDA Class 3 ·Prosthesis, Ankle, Uncemented, Non-Constrained

Filler, Bone Void, Non-Osteoinduction

FDA classification

FDA Class 3 ·Filler, Bone Void, Non-Osteoinduction

Automated External Defibrillators (Non-Wearable)

FDA classification

FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Prosthesis, Ankle, Cemented, Non-Constrained

FDA classification

FDA Class 3 ·Prosthesis, Ankle, Cemented, Non-Constrained

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA classification

FDA Class 3 ·Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

System, Non-Coherent Light, Photodynamic Therapy

FDA classification

FDA Class 3 ·System, Non-Coherent Light, Photodynamic Therapy