2,317 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·MONOPREP PAP TEST
Implanted Fecal Incontinence Device
FDA Pre-Market Approval
FDA Class 3
·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Monovisc
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Ophthalmic Viscoelastic
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·EMDOGAIN
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS
Organ Care System (Ocs) Heart System
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Heart
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
Tissue Graft Of 6mm And Greater
FDA Pre-Market Approval
FDA Class 3
·ARTEGRAFT COLLAGEN VASCULAR GRAFT
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·ANGIOLINK VASCULAR CLOSURE SYSTEM
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Urinary Control System with and without InhibiZone
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400
Tissue Graft Of 6mm And Greater
FDA Pre-Market Approval
FDA Class 3
·Artegraft Collagen Vascular Graft
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Lotus Edge Valve System