980 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Organ Care System (Ocs) Heart System
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Heart
FPC/SFPC/RFPC ACETABULAR COMPONENT
FDA 510(k)
FDA Class 3
·Orthopedic
CPS ACETABULAR COMPONENT
FDA 510(k)
FDA Class 3
·Orthopedic
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·CELSIUS FLTR BI-DIRECTIONAL CATHETER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front Advance and Arctic Front Advance Pro
Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA Pre-Market Approval
FDA Class 3
·ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA Pre-Market Approval
FDA Class 3
·ESTEEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Open-Irrigated Ablation Catheters
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment,
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EPT-1000XP CARDIAC ABLATION SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·SAFIRE BLU DUO SP ABLATION CATHETERS