BEUDAMED
    10,000 results · 58ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·MC GHAN SALINE-FILLED BREAST IMPLANTS

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS MODELS 305, 310

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·STARCLOSE VASCULAR CLOSURE SYSTEM

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ADATO SIL 5000

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC MARQUIS, INSYNC MAXIMO, INSYNC SENTRY AND INSYNC II MARQUIS

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEVEST

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed Intrathecal Catheters

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GELSYN-3

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SUPARTZ FX

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

    FDA Pre-Market Approval
    FDA Class 3 ·Ceramax Ceramic Total Hip System

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995

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

    FDA Pre-Market Approval
    FDA Class 3 ·Trident Acetabular System: Trident Alumina Inserts

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·POLY-SAFE(TM) A-TRACK(TM) PACING LEADS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MERLIN HOME 6.1M

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE ICD SYSTEM