973 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
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
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
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Covera Vascular Covered Stent
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
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Lutonix Drug Coated Balloon
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx®
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
FDA classification
FDA Class 3
·Whole Blood Pre-Treatment T-Cell Enrichment Reagent
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Sense Lead
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Epicardial Pacing Lead
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Sense Lead
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSUREFIX NOVUS LEAD
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure SP Novus Lead, Vitatron Impulse II Lead
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Fix Novus Lead (4076, 5076)
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·IsoFlex
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC SELECTSECURE LEAD MODEL 3830
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead