528 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR CONSOLE AND FOOT PEDAL)
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
Mr-Guided Focused Ultrasound System
FDA classification
FDA Class 3
·Mr-Guided Focused Ultrasound System
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA classification
FDA Class 3
·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided