System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

Cream For X-Ray Attenuation

FDA classification

FDA Class 2 ·Cream For X-Ray Attenuation

Dental Abutment Design Software For Dental Laboratory

FDA classification

FDA Class 2 ·Dental Abutment Design Software For Dental Laboratory

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Cardiovascular Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Cardiovascular Machine Learning-Based Notification Software

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

FDA classification

FDA Class 2 ·Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL TISSUE ADHESIVE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

FDA Pre-Market Approval

PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER MX2 BALLOON DILATATION CATHETER

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)