Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject W Trabecular Micro-Bypass System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

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

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER AND CABLE

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PCM CERVICAL DISC

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A)

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM