Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS CORNEAL IMPLANTS

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System (Monorail and OVer-The-Wire)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled RF Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac RF Ablation System(also branded as as Blazer (II XP, PRime XP); IntellaTip MiFi XP; IntellaNav XP a

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY XR TORIC

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express SD Monorail Premounted Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (rebrand of PROMUS Element Plus)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables

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

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL SNoW™ Absorbable Hemostat

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR™ Peptide Enhanced Bone Graft

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere (comfilcon A)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II ™ Cooled Ablation Catheter and Cable