BEUDAMED
    10,000 results · 47ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 3 ·Covera™ Vascular Covered Stent

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System with Navigation and Touch

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EON MINI IPG NEUROSTIMULATION SYSTEM

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM, ARCTIC FRONT ADVANCE CARDUAC CRYIABKATUIB CATHETER, CRYOCONSOLE AND ACCESSORIE

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ACS MULTI-LINK DUET CORONARY STENT SYSTEM

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·PMA NIT-OCCLUD PDA

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLANAV™ Ablation Cathet

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc® C

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BioGlue® Surgical Adhesive

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

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

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