2,134 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROSTHESIS
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Saluda Medical Evoke SCS System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM SACRAL NERVE STIMULATION SYSTEM
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·AngioJet Rheolytic Thrombectomy System, AngioJet Ultra XMI/AngioJet Ultra Spiroflex/AngioJet Ultra Distaflex Thrombectom
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·LAP-BAND
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET XMI THROMBECTOMY SET, ANGIOJET SPIROFLEX THROMBECTOMY SET, ANGIOJEET SPIROFLEX VG THROMBECTOMY SET, ANGIOJET DI
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire Upper Airway Stimulation System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·Spatz3 Adjustable Balloon System