BEUDAMED
    1,625 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc® L

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRODISC L TOTAL REPLACEMENT

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest Wearable Defibrillator (Model 4000)

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·SYNTHES PRODISC-L TOTAL DISC REPLACEMENT

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc C Total Disc Replacement

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·ANIMAS VIBE SYSTEM

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·VITREON(R)

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest Wearable Defibrillator

    Gases Used Within Eye To Place Pressure On Detached Retina

    FDA Pre-Market Approval
    FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest® Wearable Defibrillator

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS KRAS MUTATION TEST

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 pharmDx