Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System (Implant System), PASCAL Precision Transcatheter Valve Repair System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S4 IR EXCIMER LASER SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VISUMAX FEMTOSECOND LASER

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Photopheresis System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V/nano Everolimus Eluting Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval

FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval

FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VisuMax Femtosecond Laser