82 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD
Microspheres Radionuclide
FDA Pre-Market Approval
FDA Class 3
·SIR-Spheres Y-90 resin microspheres
Analyzer, Data, Obstetric
FDA Pre-Market Approval
FDA Class 3
·STAN S31 SYSTEM
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
FDA Pre-Market Approval
FDA Class 3
·FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable,
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK® CR2 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·DEMA/DIVA IMPLANTABLE PULSE GENERATORS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·GEM & MARQUIS FAMILY ICD'S
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·ACTIVITRAX PACEMAKER FAMILY
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC JEWEL/GEM ICD'S
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC/VITATRON CARELINK PROGRAMMER
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·KAPPA 400 PACEMAKER FAMILY
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC GEM ICD