Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·TransPyloric Shuttle/TransPyloric Shuttle Delivery Device

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify Cervical Artificial Disc

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION CATHETER AND CABLE

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 (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING 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 Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring 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 II

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

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY

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