131 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·Pulse, PulseDuo, DemiPulse, DemiPulseDuo, AspireHC, Aspire SR Generators.
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LifeVest Wearable Defibrillator
Stimulator, Autonomic Nerve, Implanted (Depression)
FDA Pre-Market Approval
FDA Class 3
·ASPIRESR GENERATOR -MODEL 106
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Analyzer Adaptors, Cable, Patient Cable; ECG Cable, Output Adaptor
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CRYOABLATION SYSTEM
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·CareLink SmartSync Micra VR App, CareLink SmartSync Micra AV App
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·LATITUDE NXT PATIENT MANAGEMENT SYSTEM
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·PSW 2202.U and NEO 2202.U
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·LATITUDE CONSULT SYSTEM
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·Renamic Neo Programmer
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·REVEAL DX, REVEAL XT
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460
Pacemaker/Icd/Crt Non-Implanted Components
FDA Pre-Market Approval
FDA Class 3
·PSW 2201.U/1 and NEO 2201.U/1