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

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Catheter, HeartLight X3 Console V2

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC-HALL PROSTHETIC HEART VALVE

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER-THE-WIRE RENAL STENT SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM21S Growth Factor Enhanced Matrix

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14-day Flash Glucose Monitoring System