BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    ReyaGel (RG03 - MTP gel 3mL)

    FDA 510(k)
    FDA Unclassified ·Unknown

    BodiTrak

    FDA UDI
    Vista Medical Ltd·07540150601533·Hi-Res Seat

    MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INSUFLOW SYNERGY XL PORT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

    PULSE GEN MODEL 101

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 14, 2008

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 2, 2011

    CANE

    FDA Adverse Event
    Malfunction ·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code IPS·October 4, 2012

    BD SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·April 25, 2025

    BD SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·April 25, 2025

    BD SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·April 25, 2025

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014