BEUDAMED
    9,409 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD

    S.A.F. ACETABULAR CUP WITH POROUS COATING

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    FMS MODEL 110

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    KM-3 ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    ATH METAL:UHMWPE TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    POROUS-COATED TITANIUM ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    Lens, Contact, Orthokeratology, Overnight

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

    Lens, Contact, Orthokeratology, Overnight

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

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

    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 Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR

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

    FDA Pre-Market Approval
    FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™

    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

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)