878 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·Trident(R) Acetabular System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure Preloaded IOL System / Model B1PC (Clear
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NexGen LPS-Flex / LPS Mobile Bearing Knee System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Tecnis CL
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Sensar 1-piece IOL, Tecnis 1-piece IOL, Tecnis 1-piece Optiblue IOL, Preloaded Tecnis 1-piece IOL, Preloaded Tecnis 1-pi
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Tecnis 3-piece Acrylic Monofocal
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Eyhance Toric II, Model ICU, TECNIS Eyhance Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy T
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNX VASCULAR CLOSURE DEVICE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PreVue Pre-Loaded System
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Bronchial Thermoplasty System
FDA Pre-Market Approval
FDA Class 3
·ALAIR BRONCHIAL THERMOPLASTY SYSTEM