BEUDAMED
    2,727 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Solesta Injectable Gel

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ACCULINK CAROTID STENT SYSTEMS

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (CSS)

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Deflux Injectable Gel

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK VISION FAMILY OF CORONARY STENT SYSTEMS (CSS)

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·S-SERIES CORONARY STENT SYSTEMS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·DRIVER CORONARY STENT SYSTEMS

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Refyne, Restylane Defyne Injectable Gels

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Lotrafilcon B soft Contact Lenses for daily and extended wear

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 770G System

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    FDA Pre-Market Approval
    FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION