494 results · 18ms · Sources: EU EUDAMED, US FDA

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Evolut PRO+ System and Medtronic Evolut FX System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro 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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro 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

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Flash Glucose Monitoring System

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·PyloPlus UBT System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic D-Light C (PDD) System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Core Valve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Valve EnVeo R Delivery Catheter Sys

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve™ Evolut™ R DCS (EnVeo R DCS), Medtronic CoreValve™ Evolut™ PRO DCS (EnVeo PRO DCS), Medtronic Evolut

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System