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

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

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)

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 GENERATION PSA

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)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD LEADS/VITATRON LEGACY DR/D/II/VISA/CAPSURE LEAD/BRILLIANT S+VDD

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

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000XP CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM