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

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T SPOT-TB Test

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

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

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE FAMILY OF ICDS

    Iliac Covered Stent, Arterial

    FDA Pre-Market Approval
    FDA Class 3 ·LifeStream Balloon Expandable Vascular Covered Stent

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Lyft with Lidocaine Cannula Injection

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM VOLUMA XC

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Rotablator™ and ROTAPRO™ Rotational Atherectomy Systems

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·HEART LASER CO2 TMR SYSTEM

    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

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Advisa DR, DR MRI and SR MRI IPG

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane® Eyelight

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, and Viva CRT-P

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SENOCLAIRE