Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·RayOne EMV

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR MODEL 2880 SOFTWARE APPLICATION

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

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 ·EPT-1000 CARDIAC ABLATION SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2901 PROGRAMMERR SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Perfluoron

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2901 PROGRAMMER

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS and Micra TPS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS-SWISS DOLORCLAST

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS SWISS DOLORCLAST

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories