1,014 results · 23ms · Sources: EU EUDAMED, US FDA

Implant, Intragastric For Morbid Obesity

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses

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 ·Comflicon 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

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Aptima HPV Assay

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity XR Toric, Biofinity Toric Multifocal

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·AquaTech Plus Premium multifocal

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, Biofinity Toric XR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTENDED WEAR

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 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·NUVASIVE'S PCM CERVICAL DISC

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval
FDA Class 3 ·TITRATOR{TM} MODEL 10K

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli Cooled Rf Ablation System