Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO(TM) INTRAVASCULAR RADIOTHERAPY SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Gen V CryoConsole

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

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

FDA Pre-Market Approval

FDA Class 3 ·Gen V CryoConsole RoHS Compliant

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2 and SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2 A209, SICD MRI A219

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·A209 SICD Gen 2, A219 SICD MRI

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODELS 7070,7071,7071M,SYNERGEST(TM)II PULSE GEN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·A209 SICD Gen 2, A219 SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·A209 SICD Gen 2, A219 SICD MRI

FDA Pre-Market Approval

GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST