138 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX FAMILY OF ICDS AND CRT-DS
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·H.E.L.P. PLASMAT FUTURA SYSTEM
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·Gore Cardioform ASD Occluder
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·GORE CARDIOFORM SEPTAL OCCLUDER
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·ADEPT Adhesion Reduction Solution
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·nGEN Pump
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·LIPOSORBER LA-15 System
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA AND SCULPTRA AESTHETIC
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
BAGS, PLASTIC, STERILE FOR GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·VITAGEL SURGICAL HEMOSTAT
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·TARGIS SYSTEM
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·Oxford Partial Knee System
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J & C LOOP MODEL PA36
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Gambro Prismaflex TPE 2000 Set