10,000 results
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47ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards INTUITY Elite Valve System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·WOLVERINE Coronary Cutting Balloon®
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Bellafill® Dermal Filler
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiCath Contact Force Ablation Catheter, Sensor Enabled
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
FDA Pre-Market Approval
FDA Class 3
·VENTANA MMR RxDx Panel
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MitraClip G4 Delivery System
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS 2 MONORAIL AND OVER-THE-WIRE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·JUVEDERM HYALURONATE GEL IMPLANTS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE EPICARDIAL PACING LEAD
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-AB-EBK PLUS ASSAY
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·LEAD ANCHORING SLEEVE KIT
Stimulator, Fetal, Acoustic
FDA Pre-Market Approval
FDA Class 3
·COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+/CAPSURE
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CADENCE FAMILY OF ICDS
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·RX ACCULINK & ACCULINK CAROTID STENT SYSTEM