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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Sustem

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Touch Dispenser

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN & SEVEN PLUS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify® Cervical Artificial Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify Cervical Artificial Disc

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval

FDA Class 3 ·LimFlow System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric Multifocal and Biofinity XR Toric (comfilconA)

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·DERMAGRAFT-TC(TM)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Cobra PzF NanoCoated Coronary Stent System