Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELUTE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION CATHETERS

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSCULPT SCORING BALLOON CATHETER

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSCULPT PTCA SCORING BALLOON CATHETER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject® Trabecular Micro-Bypass System Model

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR-PERLTM Ridaforolimus Eluting Coronary Stent System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent® Trabecular Micro-Bypass Stent System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT STENT GRAFT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·INTRAOCULAR LENS

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus Microstent

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2