3,092 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Prestige LP Cervical Disc
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIMATORY
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MEMORYGEL BREAST IMPLANT
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·HER OPTION CYROABLATION THERAPY SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA
Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
FDA Pre-Market Approval
FDA Class 3
·UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE ASSAY
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·NOVOCURE NOVOTTF-100A SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S
Stimulator, Autonomic Nerve, Implanted (Depression)
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·OPEN PIVOT BI-LEAFLET HEART VALVE
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·OcuCoat OVD
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·Gore Tigris Vascular Stent
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG THORACIC ENDOPROSTESIS