689 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Chilli Cooled RF Ablation System
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Blazer II Cardiac Ablation System and Cable
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Ranger Paclitaxel-Coated PTA Balloon Catheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Prime XP and IntellaTip MiFi XP
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Blazer Prime HTD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer Open-Irrigated Ablation Catheter
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·WLOVERINE Coronary Cutting Balloon
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER OPEN-IRRIGATED ABLATION CATHETER
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·Express® SD Renal Monorail Premounted Stent System
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Blazer II XP Cardiac Ablation Catheter and Cable
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·Rotablator Rotational Atherectomy System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·Carotid WALLSTENT Monorail Endoprosthesis System