689 results
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18ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST; INTRINSIC; MARQUIS; ONYX; SECURA; VARIOUS FAMILIES OF GEM, MAXIMO, PROTECTA, & VIRTUOSO
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CAPSURE/ENTRUST/GEM/II/III/INTRINSIC/MARQUIS/MAXIMO/II/ONYX/SECURA/VIRTUOSO/II
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST, GEMFAMILY, INTRINSCI, MARGUIS, MAXIMO FAMILY, ONYX, PROTECTA FAMILY,SECURA FAMILY,VITITUSO, EVERA FAMILY
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST, INTRINSIC, MARQUIS, ONYX, SECURA, & VARIOUS FAMILIES/MODELS OF GEM, MAXIMO, PROTECTA, & VIRTUOSO
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VIRTUOSO,ENTRUST,MAXIMO,INTRINSIC,MARQUIS,CONCERTO,PROTECTA,SECURA,CONSULTA,GEM,AND ONYX FAMILIES OF ICDS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4,
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EnTrust, Gem,Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4 Prote
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·CONSULTA CRT-P AND SYNCRA CRT-P
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay