3,100 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·INSPIRE II UPPER AIRWAY STIMULATION SYSTEM
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·On-X Ascending Aortic Prosthesis
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment
Tissue Adhesive Internal Use
FDA Pre-Market Approval
FDA Class 3
·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·ARISTA AH ABSORBABLE HEMOSTAT AND FLEXTIP APPLICATORS
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Evoke® SCS System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SKINVIVE by Juvederm
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·INSTAT COLLAGEN HEMOSTAT
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·PROMRI ICD/CRT-D SYSTEM
Optical Diagnostic Device For Melanoma Detection
FDA Pre-Market Approval
FDA Class 3
·MELAFIND
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL DURAL SEALANT SYSTEM
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·SEPRAFILM ADHESION BARRIER
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR AFP ASSAY
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ATLAS II+ HF CRT-D & PROMOTE HE CRT-D
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·ENTERYX PROCEDURE KIT
Intracranial Coil-Assist Stent
FDA Pre-Market Approval
FDA Class 3
·Neuroform Atlas® Stent System
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Coseal Surgical Sealant
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge