BEUDAMED
    947 results · 39ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRXCELL PMS US STUDY NIRTRAKS

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify® Cervical Artificial Disc (One-Level)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™

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

    FDA Pre-Market Approval
    FDA Class 3 ·RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, MOMENTUM™ X4, VIGILIANT™, VIGILIANT™ X4

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Microny SR+ Regency SC+

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Allure Quadra, Quadra Allure MP, Frontier

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic +, Atlas/II/+, Convert/+, Photon

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Endurity, Accent, AddVent, Identity, Entity, Paragon III Sustain

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

    FDA Pre-Market Approval
    FDA Class 3 ·Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·Hydrus Microsent

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Biosense Webster NaviStar ThermoCool Catheter

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX DEVICE

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx Device

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACANALYSIS CDX

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·BRACAnalysis CDx®

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice CDx