Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NUVASIVE PCM CERVICAL DISC SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER & CABLE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Voyant Monthly, Voyant Monthly Premium, Voyant Monthly Toric, Voyant Monthly Multifocal

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER AND CABLE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV-GT Assay

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·AIA-PACK PSA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ST AIA-PACK PA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·AIA-PACK PSA

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMUNOASAY, PSA