493 results
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21ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·Y Adaptor/Extender Kit, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Su
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs, TECNIS Eyhance IOL, TECNIS Eyhan
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC L
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·Y Adaptor/Extender Kit, DF-1/IS-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, Lead Adaptor, Sprint Quatro Lead, Su
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT/QUATTRO/SUBCUTANEOUS LEAD/SUB-Q TUNNELING TOOL/TRANSVENE CS/SVC/DF1/RV/SUBQ/SVC
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs,
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA SR MRI
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER