985 results · 21ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli II TM Cooled Ablation Catheter and Cable

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·DERMAGRAFT

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Touch Dispenser

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Simplify® Cervical Artificial Disc (2 Level)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Cardiac Ablation Percutaneous Catheter

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY XR TORIC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Simplify® Cervical Artificial Disc

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring Systems

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FLUOROPERM RGP CONTACT LENSES

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND Adjustable Gastric Banding System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity Sphere (comfilcon A)

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 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses, Biofinity Sphere/Biofinity XR Sphere, Biofinity Energys, Bi

Lenses, Soft Contact, Extended Wear

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

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Aptima HBV Quant Assay

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G5 Mobile Continuous Glucose Monitoring System

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES