325 results · 18ms · Sources: EU EUDAMED, US FDA

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Liver

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare® HVAD System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·Implantable Miniature Telescope

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)