29 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK RELIANCE 4-SITE Leads
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·Animas Vibe System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Philips HeartStart FR3 Defibrillator
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·ORTHOPAK BONE GROWTH STIMULATOR
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC COREVALVE SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC COREVALVE SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES