230 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·Protégé GPS Self-Expanding Peripheral Stent System, and Protégé RX Carotid Stent System
Processor, Cervical Cytology Slide, Automated
FDA Pre-Market Approval
FDA Class 3
·THINPREP 2000 SYSTEM
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® System
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
FDA 510(k)
FDA Class 3
·Cardiovascular
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·COREVALVE EVOLUT BIOPROSTHESIS, CORE VALVE BIOPROSTHESIS, ACCUTRAK DELIVERY CATHETER SYSTEM, GEN 3 & GEN4 COMPRESSION LO
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONCENTRO II CRT-D
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VIRTUOSO II ICD DR/VR
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA classification
FDA Class 3
·Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL)