BEUDAMED
    1,516 results · 30ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MINIMED 530G SYSTEM

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR

    Gastric Emptying Breath Test

    FDA Pre-Market Approval
    FDA Class 3 ·GASTRIC EMPTYING BREATH TEST (GEBT)

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

    Device, Dermal Replacement

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·ACTROS+

    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

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·BIOTRONIK INOS2+ CLS PULSE GENERATOR AND B-K05.V.U PROGRAMMER SOFTWARE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·STELIX/STELIX II STEROID ELUTING PACING LEADS; EASYTURN/EASYTURN ACCESSORY SYTLET KITS

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Access AFP Reagents on the Access Immunoassy Systems

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·ADHERUS AUTOSPRAY DURAL SEALANT

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Guardian Connect System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VITALITY HE MODEL T182 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AND THE CONSULT PROGRAMMER SOFTWARE APPLICAT