BEUDAMED
    10,000 results · 38ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant

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

    FDA Pre-Market Approval
    FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Pulse Generator, Permanent, Implantable

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·Gynecare Interceed Absorbable Adhesion Barrier

    Permanent Defibrillator Electrodes

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

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Sprint Quattro Lead

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·PERSONAL THERAPY MANAGER (MYPTM)

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SLX 58/11-BP, SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,SLX 65/11-BP,SLX 65/13-BP,SLX 65/14-BP,SLX 65/15-BP,SL

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Sprint Quattro Lead

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra AV TPS, Micra TPS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P