BEUDAMED
    947 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORETEC HEARTMATE XVE LVAS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS)

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

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

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Neuro Cochlear Implant System

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)

    Device, Dermal Replacement

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE 2000 XPI HBSAG

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

    FDA Pre-Market Approval
    FDA Class 3 ·EXOGEN 4000+ BONE HEALING SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·PRAKTIS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·FOCALPOINT SYSTEMCREENING SYSTEM