1,123 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectr
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·STARCLOSE VASCULAR CLOSURE SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·WaveWriter Alpha, WaveWriter Alpha 16
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus R32, Vercise Genus R16
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEXGEN COMPLETE KNEE SOLUTION
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS Therapy System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Alternative Active Anchor (part number 104504)
Sealant, Dural
FDA classification
FDA Class 3
·Sealant, Dural
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen BRAF V600E RGQ PCR Kit
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·Shield
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Agilent Resolution ctDx FIRST
Immunohistochemistry Assay, Antibody, Folr1
FDA Pre-Market Approval
FDA Class 3
·VENTANA FOLR1 (FOLR-2.1) RxDx Assay
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen FGFR RGQ RT-PCR Kit
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·MI Cancer Seek