142 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Defibtech's Automated External Defibrillator (AED) System
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·COROX OTW-L BP LEADS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·COROX OTW-L BP LEADS
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Mapping and Ablation Catheter
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Affera Sphere-9 Mapping and Ablation Catheter
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·COROX OTW-L BP LEFT VENTRICULAR PACING LEAD
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Mapping and Ablation Catheter, Tubing Set
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Ablation and Mapping Catheter - AFR-00001
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·CoreValve Evolut R, PRO Bioprosthesis
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·DiamondTemp Ablation System with the EnSite X Mapping System
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·PAPNET (R) TESTING SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TACTICATH QUARTZ SET
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiCath Contact Force Ablation Catheter, Sensor Enabled
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiCath Contact Force Ablation Catheter, Sensor Enabled
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C