BEUDAMED
    969 results · 33ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY (COMFILCON) SOFT CONTACT LENS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·QUICKSEAL ARTERIAL CLOSURE SYSTEM WITH Q-FOAM

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    FDA Pre-Market Approval
    FDA Class 3 ·PROGENSA PCA3 ASSAY

    Lenses, Soft Contact, Extended Wear

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

    Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

    FDA Pre-Market Approval
    FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx Downstream Cartridge

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM SHORT TERM GLUCOSE SENSOR (STS)

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·AquaClear Premium

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HPV Assay

    Lenses, Soft Contact, Extended Wear

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

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSCYTE

    Contrast Media, Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY