Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric (Comfilcon A) soft (Hydrophilic) contact lenses for extended wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND Adjustable Gastric Banding System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Maestro 4000 Controller Firmware

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·TRANSCYTE (DERMAGRAFT-TC)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND Adjustable Gastric Banding System