Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

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 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SHORT TERM GLUCOSE SENSOR (STS)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLANTINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

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

FDA Pre-Market Approval

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

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval

FDA Class 3 ·LimFlow System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SURESTAT ARTERIAL CLOSURE SYSTEM

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli Cooled Rf Ablation System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify® Cervical Artificial Disc