420 results · 21ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX2 Endovascular AAA System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

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

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Nevro Corp Senza Spinal Cord Stimulation (SCS) System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

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

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·Ceramax Ceramic Hip System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Drug Delivery Infusion Pumps SynchroMed

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS® Total Knee System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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