3,094 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MiniMed 630G System
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·iPro2 CGM System with Enlite Sensor
Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA Pre-Market Approval
FDA Class 3
·ESTEEM
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx
Kit, Assay, Estrogen Receptor
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ER-EIA MONOCLONAL DIAG. KIT
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION BIONIC EAR SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G INSULIN PUMPS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 HYBRID SYSTEM
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G Insulin Pump
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·ENLITE GLUCOSE SENSOR, ENLITE SERTER
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 HYBRID SYSTEM
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G INSULIN PUMP
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® 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