396 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EVERA S DR ICD, S VR ICD; EVERA XT DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PRO
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Compai MRI Quad/Consulta/Maximo II/Pro
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Protecta ICD, Pro
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ETRINSA 8/6 DR-T/SR-T, ETRINSA 6 DR/SR, EPYRA 8/6 DR-T/SR-T, ELUNA 8 DR-T/SR-T DR/SR PRO MRI PACEMAKERS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Pro
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD