937 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implant, Corneal, Refractive
FDA Pre-Market Approval
FDA Class 3
·KAMRA INLAY
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·M6-C Artificial Cervical Disc
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI family of Pacemakers
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·OBALON BALLOON SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve System / Medtronic CoreValve Evolut R System/ Medtronic CoreValve Evolut PRO System
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·SCULPTRA
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Prometra Programmable Infusion Pump System
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Ranger Paclitaxel-Coated PTA Balloon Catheter
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·INCRAFT AAA Stent Graft System
Catheter, Balloon, Urethral, Drug-Coated
FDA Pre-Market Approval
FDA Class 3
·Optilume Urethral Drug Coated Balloon
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Assurity, Assurity+, Endurity, Accent family of Pacemaker
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Valve, Pulmonary
FDA Pre-Market Approval
FDA Class 3
·Spiration Valve System
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Intracranial Coil-Assist Stent
FDA Pre-Market Approval
FDA Class 3
·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.