Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·7F FREEZOR CARDIAC CYROABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN BONE HEALING SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·SWEDISH ADJUSTABLE GASTRIC BAND

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·VENASEAL CLOSURE SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·Absorbable Collagen Plug for Dental Surgery, Absorbable Collagen Tape for Dental Surgery

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN ULTRASOUND BONE HEALING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·Raindrop Near Vision Inlay

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Straight Left Ventricular Lead

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems