180 results · 18ms · Sources: EU EUDAMED, US FDA

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Spatz3 Adjustable Balloon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Spatz3 Adjustable Balloon System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Prometra Programmable Infusion Pump System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·OBALON BALLOON SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon Kit

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® CR2 Defibrillator

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim SCS Neurostimulation System