10,000 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·Epic Vascular Self-Expanding Stent System
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PMMA Single-Piece Anterior Chamber Intraocular Lens
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·GELSYN-3
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·H55 HYDROPHILIC CONTACT LENS
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SURGIFOAM® Absorbable Gelatin Sponge
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System, Verify® Evaluation System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Open-Irrigated Ablation Catheter
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectr
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (etafilcon A) Brand Contact Lenses
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SUPARTZ
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ADVISA DR