BEUDAMED
    2,243 results · 21ms · 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 ·ANTI-HBC IGM

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    FDA Pre-Market Approval
    FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS TAQMAN HBV TEST

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·S670 RAPID EXCHANGE CORONARY STENT SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCYTE

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

    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)

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Saluda Medical Evoke SCS System

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS ITEC PRELOADED DELIVERY SYSTEM

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·PERFLURON

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SELENIA DIMENSIONS 3D SYSTEM