BEUDAMED
    78 results · 22ms · Sources: EU EUDAMED, US FDA

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    Fluorescence Imaging For Breast Cancer Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Lumicell Direct Visualization System (DVS)

    Fluorescence Imaging For Breast Cancer Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Lumicell Direct Visualization System

    Fluorescence Imaging For Breast Cancer Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Lumicell Direct Visualization System (DVS)

    Fluorescence Imaging For Breast Cancer Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Lumicell Direct Visualization System (DVS)

    Fluorescence Imaging For Breast Cancer Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Lumicell Direct Visualization System (DVS)

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    FDA Enforcement
    Class II ·Ongoing·Lumicell, Inc.·September 10, 2025

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    FDA Recall
    Open, Classified ·Lumicell, Inc.·Product code SAW·July 31, 2025

    LessRay

    FDA UDI
    Nuvasive, Inc.·00887517756732·LessRay Collar, 9" C-Arm

    PEGASUS

    FDA UDI
    PEGASUS RESEARCH CORPORATION·00612223230012·HUMIDIFIER HEATER BRACKET, VISION/PHILIPSV60 FIT

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707022732·CALIBRA BANDS 2ND MOLAR n.SUL 14

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193115740·HA PEEK EVOS Straight, ,14mmx10mmx 30mm , FLAT ...

    MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·ADHERUS AUTOSPRAY DURAL SEALANT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas® EZH2 Mutation Test

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·May 22, 2026

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·April 10, 2025

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code POE·October 23, 2024

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code POE·March 27, 2025

    ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code POE·April 18, 2025

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·May 14, 2026