417 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede System
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX Ceramic Hip System
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·PATH VYSION HER-2 DNA PROBE KIT
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT
Fluid, Intraocular
FDA Pre-Market Approval
FDA Class 3
·PERFLUORON
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Aptima HBV Quant Assay
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·EON NEUROSTIMULATION SYSTEM
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace RNS System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Ophthalmic Sealant
FDA Pre-Market Approval
FDA Class 3
·RESURE SEALANT
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace RNS System
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM