161 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Heart Failure Risk Status (HFRS), Triage-HF
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·LIPOSORBER LA-15 SYSTEM
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Intrasaccular Flow Disruption Device
FDA Pre-Market Approval
FDA Class 3
·Woven EndoBridge Aneurysm Embolization (WEB) System
Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA Pre-Market Approval
FDA Class 3
·Esteem® Totally Implantable Hearing System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·CraniSeal Dural Sealant
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP and CP with SmartAssist
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Onclarity HPV Assay
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT VISCOELASTIC SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Remodulin
Catheter, Percutaneous, Long Term, Intraspinal
FDA Pre-Market Approval
FDA Class 3
·PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Surpass Streamline Flow Diverter
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Pipeline Flex Embolization Device (Pipeline Flex); Pipeline Flex Embolization Device with Shield Technology (Pipelin
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·PIPLINE TM EMBOLIZATION DEVICE
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Surpass Streamline Flow Diverter System, Surpass Evolve Flow Diverter System
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Pipeline Flex Embolization Device
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Surpass Elite Flow Diverter System