BEUDAMED
    1,859 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GenVisc 850

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·Animas, Vibe System

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest Wearable Defibrillator

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEVEST® WEARABLE DEFIBRILLATOR

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK Automated External Defibrillators (AEDs)

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator

    Transvenous Temporary Phrenic Nerve Stimulator

    FDA Pre-Market Approval
    FDA Class 3 ·AeroPace® System

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·COOL CAP SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRODISC-L TOTAL DISC REPLACEMENT

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator

    Aspiration Therapy System

    FDA Pre-Market Approval
    FDA Class 3 ·AspireAssist

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·ProDisc-L Total Disc Replacement