2,258 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Cervista HPV HR Assay
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 ARTIFICIAL URINARY SPHINCTER
Reader, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·ThinPrep Integrated Imager
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·Urinary Control System
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Urinary Control System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ORBERA Intragastric Balloon System
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM, 91-4200US, 91-4201US, 91-4205US
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC ONE
Implanted Fecal Incontinence Device
FDA Pre-Market Approval
FDA Class 3
·ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER