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

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·Maestro Rechargeable System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

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

FDA Pre-Market Approval
FDA Class 3 ·OrganOx metra System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Deep Brain Stimulation (DBS) Therapy for Epilepsy

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·Implantable Miniature Telescope (IMT)

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·PMA NIT-OCCLUD PDA

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella Left Ventricular Support Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System

System, Oxygen, Aqueous

FDA Pre-Market Approval
FDA Class 3 ·TherOx DownStream System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MemoryGel Breast Implants

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Orbera Intragastric Balloon

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Sapien XT Transcatheter Heart Valve

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ProMRI ICD/CRT-D System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·ACUITY X4

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·Barostim System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)