BEUDAMED
    937 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·Paradigm Spine Coflex Interlaminar Stabilization Device

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix Drug Coated Balloon

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid L24 Implant System

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Implant, Intragastric For Morbid Obesity

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

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·iDESIGN Refractive Studio; STAR Excimer Laser System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SMART-MSP

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella Ventricular Support Systems

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MemoryShape Breast Implants

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

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

    FDA Pre-Market Approval
    FDA Class 3 ·R3 Delta Ceramic Acetabular System

    Placental Alpha Microglobulin-1 Immunoassay

    FDA Pre-Market Approval
    FDA Class 3 ·PartoSure Test

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Gore CardioForm Septal Occluder

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE CARDIOFORM Septal Occluder

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate

    Diagnostic Low Electric Field

    FDA Pre-Market Approval
    FDA Class 3 ·MarginProbe System