BEUDAMED
    10,000 results · 31ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Biosense Webster NaviStar Thermocool Catheter

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROPACE RNS SYSTEM

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Axium Leads and other accessories

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

    FDA Pre-Market Approval
    FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Spiration Valve System

    Joint, Temporomandibular, Implant

    FDA Pre-Market Approval
    FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

    Implant, Intragastric For Morbid Obesity

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·SOLESTA

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

    FDA Pre-Market Approval
    FDA Class 3 ·Quadripolar Pacing

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT TOTAL PSA

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTATIONAL ATHERECTOMY SYSTEM

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON- TB GOLD TEST