296 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
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·EMS-SWISS DOLORCLAST
Generator, Shock-Wave, For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·EMS SWISS DOLORCLAST
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch
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
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
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·PerClot Polysaccharide Hemostatic System