3,055 results · 18ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SJM ELLIPSE AND FORTIFY ASSURA ICDS

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC MODEL 7272

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC REGISTRY

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Stent, Superficial Femoral Artery

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

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS & CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTH

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Arista AH Absorbable Hemostatic Particles

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Hybrid L24 CI System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter