2,097 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Lacrosse NSE ALPHA Coronary Dilatation Catheter
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Lacrosse NSE ALPHA Coronary Dilatation Catheter
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Durata, Optisure
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·Microny family of Pacemakers
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Tendril STS, UltiPace
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Assurity, Assurity+, Endurity, Accent family of Pacemakers
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Aveir Leadless System
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Evoke® SCS System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Evoke® SCS System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Evoke SCS System