969 results · 23ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli II Cooled Ablation Catheter andCable

Controller, Closed-Loop, Blood-Pressure

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

Sensor, Glucose, Invasive, Non-Adjunctive

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 (COMFILCON A) SOFT CONTACT LENS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·TRANSCYTE

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO 4000 CARDIAC ABLATION SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCON G4 PLATINUM CGM

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval
FDA Class 3 ·Progensa PCA3 Assay

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval
FDA Class 3 ·Progensa PCA3 Assay

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ReShape Lap-Band System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI COOLED ABALATION SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCON SEVEN SENSOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE

Prosthesis, Intervertebral Disc

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