Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION CATHETER AND CABLE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric, Biofinity Toric Multifocal

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx DownStream System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

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 SEVEN SYSTEM

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 G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOL ABLATION CATHETER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

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 System

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay