2,711 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ADIANA PERMANENT CONTRACEPTION SYSTEM
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 System
Ventilator, High Frequency
FDA Pre-Market Approval
FDA Class 3
·MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF(GRAFTSKIN)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·Atellica® IM Alpha Fetoprotein (AFP) Assay
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·IN MOTION LUMBAR ARTIFICIAL DISC
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESIS
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation (SNM) System for Bowel Control
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Intera 3000 Hepatic Artery Infusion Pump
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NOVASURE IMPENDANCE CONROLLED ENDOMETRIAL ABLATION SYSTEM
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·STAARVISC II & SHELLGEL SODIUM HYAURONATE
Tissue Graft Of 6mm And Greater
FDA Pre-Market Approval
FDA Class 3
·Artegraft Collagen Vascular Graft
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR ANTI-HBS ASSAY
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYLAFORM (HYLAN B GEL); PREVELLE SILK