811 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Immunohistochemistry Assay, Antibody, Met
FDA Pre-Market Approval
FDA Class 3
·VENTANA MET (SP44) RxDx Assay
Immunohistochemistry Assay, Antibody, Met
FDA Pre-Market Approval
FDA Class 3
·VENTANA MET (SP44) RxDx Assay
Immunohistochemistry Assay, Antibody, Met
FDA Pre-Market Approval
FDA Class 3
·VENTANA MET (SP44) RxDx Assay
Device, Angioplasty, Laser, Coronary
FDA Pre-Market Approval
FDA Class 3
·CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Multifunctional Ablation Generator (MAG)
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Multifunctional Ablation Generator (MAG)
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Testicular Hypothermia
FDA Pre-Market Approval
FDA Class 3
·REPRO-MED - THD
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNX VASCULAR CLOSURE DEVICE
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·CentriMag Circulatory Support System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER AAA ENDOPROSTHESIS
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH FLEX AAA ENDOVASCULAR GRAFT
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Synergy Ablation System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER BIFURCATED ENDOPROSTHESIS
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·EPi-Sense Guided Coagulation System