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

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA DEEP BRAIN STIMULATION SYSTEMS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Cardinal Health Multifunctional Defibrillation Electrode

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captiva Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·TransPyloric Shuttle/TransPyloric Shuttle Delivery Device

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·LifeStream® Balloon Expandable Vascular Covered Stent

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

Aortic Stent

FDA Pre-Market Approval
FDA Class 3 ·Minima Stent System