BEUDAMED
    177 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE

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

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

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE DEVICES

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision Spectra and Spectra WaveWriter Spinal Cord Stimulator

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·CHARITE ARTIFICIAL DISC

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Hydro Thermablator Endometrial Ablation System

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Epic Vascular Self-Expanding Stent System

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Innova Self-Expanding Stent System

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System

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

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

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II Cardiac Ablation System

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·UVAR XTS(TM) PHOTOPHERESIS SYSTEM