BEUDAMED
    42 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FR3 Defibrillator

    Over-The-Counter Automated External Defibrillator

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·NOVA(TM) PULSE GENERATOR 7 RX 2000(TM) PROGRAMMER

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

    Over-The-Counter Automated External Defibrillator

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

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon catheter

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·The 4Kscore Test

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 RX