BEUDAMED
    2,488 results · 16ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·STYLE 17 & 17A POSTERIOR CHAMBER IOLS

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·ORCOLON (R) (POLYACRYLAMIDE)

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DuraSeal Exact Spine Sealant System

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION ™ Coronary Orbital Atherectomy System (OAS)

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DuraSeal TM Dural Sealant System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

    Wearable Automated External Defibrillator

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTMATE(R) VE LVAS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Injectable Gel Implants

    Material, Dressing, Surgical, Polylactic Acid

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Hyaluronate Gel Implants

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·OXYCEL

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM

    Instrument, Glucose, Noninvasive Technology

    FDA Pre-Market Approval
    FDA Class 3 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Voluma XC, Vollure XC and Volbella XC

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

    Prosthesis, Breast, Inflatable, Internal, Saline

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

    Fluid, Hysteroscopy

    FDA Pre-Market Approval
    FDA Class 3 ·HYSKON (32% DEXTRAN 70)