BEUDAMED
    10,000 results · 53ms · Sources: EU EUDAMED, US FDA

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

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

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS.

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

    FDA Pre-Market Approval
    FDA Class 3 ·Fluency Plus Endovascular Stent Graft

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·STAARVISC II & SHELLGEL SODIUM HYALURONATE

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK RENEWAL RF PULSE GENERATORS

    Analyzer, Medical Image

    FDA Pre-Market Approval
    FDA Class 2 ·ONGUARD

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·MONOPREP PAP TEST

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM HBSAG/CONFIRMATORY

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRXCELL COCR CORONARYSTENT ON RX SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·GEM MODEL 7227 IMPLANTABLE DEVICE

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·DURALOC OPTION CERAMIC HIP SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·SALINED-FILLED BREAST IMPLANTS