BEUDAMED
    673 results · 19ms · 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 ·ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS

    Catheter, Sampling, Chorionic Villus

    FDA Pre-Market Approval
    FDA Class 3 ·TROPHOCAN TM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·TORAY SOFT CONTACT LENSES

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

    Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

    FDA Pre-Market Approval
    FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASOSEAL (TM)

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRESILLION PLUS COCR CORONARY STENT RX SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS

    Kit, Assay, Progesterone Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 405 SPANFLEX TM IOL

    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

    FDA Pre-Market Approval
    FDA Class 3 ·FEMSOFT URETHRAL INSERT

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Praxis Extended RAS Panel

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

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

    Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

    FDA Pre-Market Approval
    FDA Class 3 ·LAMICEL(TM)

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CSI CONTACT LENS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CYBERLITH IV UNIPOLAR PULSE GENERATOR