186 results
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26ms
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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
·CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Adaptor Assembly Cable, ECG Cable, Patient Cable, and Analyzer Cable
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ECG CABLE/CAPSURE VDD LEADS/VITATRON BRILLANT S+ VDD LEADS/VITATRON LEGACY/LEGACY II/VISA
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, FARAWAVE NAV Pulsed Field Ablation C
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·BATTERY CHECK MONITOR, CAPSURE LEAD, CARELINK PROGRAMMER, CARELINK PROGRAMMER RF HEAD, DESKTOP BOSS SOFTWARE, ECG CABLE
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li
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
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT
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