BEUDAMED
    10,000 results · 32ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE)

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·THE HEART LASER CO2 TMR SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·QuickFlex u 1258T LV Lead

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL (R) EXACT SPINE SEALANT SYSTEM

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Smartablate System Interface Cable

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Spiration® Valve System (SVS)

    Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

    FDA Pre-Market Approval
    FDA Class 3 ·Cartiva Synthetic Cartilage Implant

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Tissue Graft Of 6mm And Greater

    FDA Pre-Market Approval
    FDA Class 3 ·ProCol Vascular Bioprosthesis

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Lap-Band Adjustable Gastric Banding System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL FAMILY F LOW VOLTAGE LEADS

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Corox OTW BP

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 PharmDx