4,992 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADARVISION EXCIMER LASER SYSTEM
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ST. JUDE MEDICAL MECHANICAL HEART VALVE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·LIVIAN/RENEWAL/COGNIS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·THINLINE II/ FINELINE II
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK/ ENDURANCE/ RELIANCE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DELTA PACEMAKER SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Open Irrigated Temperature Ablation Catheter
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Ingenio Pacemakers (Advantio, Ingenio, Vitalio, Formio / Ingenio 2 Pacemakers (Altrua 2, Essentio, Proponent, Accolade)
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Emblem S-ICD, Emblem MRI S-ICD
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Trifecta Valve with Glide Technology (Trifecta GT)
Pulse-Generator, Single Chamber, Single
FDA Pre-Market Approval
FDA Class 3
·INTERTACH(R)II MODELS 262-16
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro)
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·AID(R) B/BR
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MitraClip Clip System