2,411 results · 25ms · Sources: EU EUDAMED, US FDA

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Talisman™ PFO Occluder

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH-GTO

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Patent Foramen Ovale (PFO) Occluder

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Exact Spine Sealant System

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve and Medtronic Evolut Systems

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·Xvivo Perfusion System (XPS) with Steen Solution Perfusate