3,122 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·TRANSVENE CS/SVC LEAD
Microspheres Radionuclide
FDA Pre-Market Approval
FDA Class 3
·SIR-SPHERES
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH FLEX AAA ENDOVASCULAR GRAFT
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·XACT CAROTID STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·NIRxcell CoCr Coronary Stent on RX System
Valve, Pulmonary
FDA Pre-Market Approval
FDA Class 3
·Zephyr Endobronchial Valve System