206 results
·
43ms
·
Sources: EU EUDAMED, US FDA
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Latitude NXT Patient Management System (INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO MRI; PROPONENT MRI; ACCOLADE MRI Pacemakers
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MRI Pacemakers
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·INGEVITY MRI pace/sense lead
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Ingenio 2 Pacemakers, ESSENTIO, PROPONENT, ACCOLADE MRI MODELS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Accolade MRI Pacemakers: ESSENTIO MRI, PROPNENT MRI, ACCOLADE MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Torque Wrench
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Ingevity Lead Family (passive fixation models)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Pacemaker Devices
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·INGEVITY LEADS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·INGEVITY Passive Fixation leads
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Ingevity Lead Manufacturing Changes
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·INGEVITY MRI Pace/Sense Leads
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL