138 results · 19ms · Sources: EU EUDAMED, US FDA

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