1,011 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, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·EDWARDS INTUITY Elite Valve System
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·GORE VIATORR TIPS ENDOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG Conformable Thoracic Stent Graft with Active Control System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TactiCath Quartz Contract Force Ablation Catheter
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs,
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·SOUNDTEC DIRECT SYSTEM
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (senofilcon A) Brand Contact Lenses
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT TOTAL PSA
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface