Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Xstim Spine Fusion Stimulator

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Xstim Spine Fusion Stimulator

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex ArtificialIris

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval

FDA Class 3 ·MELAFIND

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE / IMMULITE 1000 Third Generation PSA

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS Prosthetic Heart Valve (CPHV)

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

FDA Pre-Market Approval

FDA Class 3 ·CRYOABLATION CONSOLE

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

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT/ ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER FAMILIES OF DEVICES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CRYOABLATION CONSOLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYO-ABLATION CATHETER FAMILIES AND THE ARTIC FRONT

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA