BEUDAMED
    192 results · 40ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL

    Test, Urea Adult And Pediatric (Breath),

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

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE SP & CAPSURE Z

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SUREFIX

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM

    Immunohistochemistry Assay, Antibody, Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

    Immunohistochemistry Assay, Antibody, Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    FDA Pre-Market Approval
    FDA Class 3 ·MiSight 1 Day (omafilcon A)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTIP PLUS INTRASPINAL CATHETER KIT

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RELIANCE FAMILY OF LEADS

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY XR TORIC

    Sealant, Polymerizing

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

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·TRIDYNE™ Vascular Sealant

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEP TEST