2,328 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG THORACIC ENDOPROSTHESIS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Nevro Corp Senza Spinal Cord Stimulation (SCS) System
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·NATRELLE SILICONE-FILLED BREAST IMPLANTS
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·H.E.L.P. PLASMAT FUTURA SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·Optune System
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNXGRIP VASCULAR CLOSURE DEVICE
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Mr-Guided Focused Ultrasound System
FDA Pre-Market Approval
FDA Class 3
·Exablate Model 4000 System
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION BIONIC EAR SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ISERT GEMETRIC
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Intracranial Coil-Assist Stent
FDA Pre-Market Approval
FDA Class 3
·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·NATRELLE SALINE BREAST IMPLANTS