1,258 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 SYSTEM
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA CP with Smart Assist
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Pulse Generator, Pacemaker Implantble with Cardiac Resynchronization (CRT-P) and Drug Eluting Permanent Left Ventricular
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·OVATIO CARDIAC RESYNCHRONIZATION THERAPY (CRT) AND SITUS OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) LEAD
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA classification
FDA Class 3
·Temporary Non-Roller Type Left Heart Support Blood Pump
System, Appendage Closure, Left Atrial
FDA classification
FDA Class 3
·System, Appendage Closure, Left Atrial
Leadless Cardiac Resynchronization Therapy (Crt)
FDA classification
FDA Class 3
·Leadless Cardiac Resynchronization Therapy (Crt)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P and Corox OTW, Sentus (ProMRI) OTW Drug Eluting Permanent Left Ventricu
Ventricular Bypass (Assist) Device
FDA classification
FDA Class 3
·Ventricular Bypass (Assist) Device
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgic