8,447 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·iPro2 Continuous Glucose Monitoring (CGM) System with Enlite System
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
FDA Pre-Market Approval
FDA Class 3
·VENTANA MMR RxDx Panel Solid Tumors with dMMR status)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Urinary Control System with and without InhibiZone
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·WaveLight EX500 Laser System with Patient Bed Swivel 1125
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D)
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM