378 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Thermocool Smarttouch
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Thermocool Smarttouch SF
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace RNS System
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Algovita Spinal Cord Stimulation System
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·Adapta, Versa, Sensia IPG, Relia IPG
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA Pre-Market Approval
FDA Class 3
·Freestyle Libre Flash Glucose Monitoring System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Zoll R Series
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Implant, Auditory Brainstem
FDA Pre-Market Approval
FDA Class 3
·Nucleus ABI541 Auditory Brainstem Implant
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus 24 Cochlear Implant System
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·Nucleus Hybrid L24 Implant System
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·EluNIR Ridaforolimus Eluting Coronary Stent System
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·EluNIR-PERL Ridaforolimus Eluting Coronary Stent System
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·EluNIR Ridaforolimus Eluting Coronary Stent System