BEUDAMED
    136 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE SFA/PPA VASCULAR STENT SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM - SFA AND PPA

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM- SFA AND PPA

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM SFA and PPA

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK P /P2 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILIES

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx®

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EverFlex Self-expanding Peripheral Stent System (SFA/PPA) and EverFlex Self-expanding Peripheral Stent System (iliac)

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator

    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, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre 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, Non-Adjunctive, Factory-Calibrated, User-Initiated

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

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

    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