BEUDAMED
    3,981 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLogic™

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLogic™

    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL 430-07 ENDOCARDIAL PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TIR/TIJ AND POLYROX

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    STELA MODEL BJ44 AND BJ45 PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    FDA Pre-Market Approval
    FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM