494 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre 14 day Flash Glucose Monitoring System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre 14 day Flash Glucose Monitoring System
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·Freestyle Libre 14-Day Flash Glucose Monitoring System
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·Freestyle Libre Flash Glucose Monitoring System; Freestyle Libre 14 day Flash Glucose Monitoring System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Artic Front Advanced Cardiac Cryoablation Catheter, Artic Front Advanced PRO Cardiac Cryoablation Catheter
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·Freestyle Libre 14 day Flash Glucose Monitoring System
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre 14-Day Flash Glucose Monitoring System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Core Valve Evolut R System and Core Valve Evolut PRO System
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Fron Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac)
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Enveo R and EnVeo PRO Delivery Catheter System of the CoreValve
Filler, Bone Void, Non-Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT