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

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·PMA NIT-OCCLUD PDA

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Carotid Wallstent™ Monorail™ Endoprosthesis

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS® Total Knee System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Cermax® Ceramic Total Hip System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Essentio MRI / Proponent MRI / Accolade MRI / Accp;ade MRI Pacemakers

Transcatheter Septal Occluder

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

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Muscular VSD Occluder

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·FlexNav™ and Navitor Loading System, FlexNav™ Delivery System

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE, USP

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM