463 results
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27ms
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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
·RADIESSE (+) Lidocaine Derma Filler
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Tissue Graft Of 6mm And Greater
FDA Pre-Market Approval
FDA Class 3
·Artegraft Collagen Vascular Graft
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·Straumann Emdogain
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Bellafill Dermal Filter
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Durolane, Hyaluronic Acid, Stabilized Single Injection
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Juvéderm Ultra, Ultra XC, Ultra Plus XC
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity Sphere, Biofinity Toric
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-AUK PLUS ASSAY
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu