213 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS 2 MR & OTW CORONARY STENT SYSTEM
Transcervical Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·CONCEPTUS ESSURE SYSTEM
Stimulator, Neuromuscular, Implanted
FDA Pre-Market Approval
FDA Class 3
·NEUROCONTROL FREEHAND SYSTEM
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·EUFLEXXA
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·LiveWire TC Ablation Catheter and Safire Ablation Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Therapy Cool Path
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiCath Contact Force Ablation Catheter, Sensor Enabled
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·FlexAbility and FlexAbility SE Ablation Catheter
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·EPi-Sense ST RF Cable
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV 16 18/45 GENOTYPE ASSAY
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA Reagent Pack
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Aptima HPV Assay
System, Non-Coherent Light, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·CURELIGHT BROADBAND (MODEL CURELIGHT 01)