33 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Device, Angioplasty, Laser, Coronary
FDA Pre-Market Approval
FDA Class 3
·VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
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
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Foldable Acrylic IOL with OptiEdge
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR® Soft Acrylic Posterior Chamber IOL
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·Superion Indirect Decompression System
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM (ADULT)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CALRION CII BIONIC EAR SYSTEM (ADULT)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
Device, Angioplasty, Laser, Coronary
FDA Pre-Market Approval
FDA Class 3
·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES
Monitor, Intracranial Pressure, Implanted
FDA Pre-Market Approval
FDA Class 3
·COSMAN ICP TELE-SENSOR(R)
Monitor, Intracranial Pressure, Implanted
FDA Pre-Market Approval
FDA Class 3
·ICP TELE-MONITOR & ICP TELE-SENSOR