BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    TENS and EMS Stimulation (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM

    NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FIBERLASE ENDURE CO2 FIBER

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

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    WHEELCHAIR ACCESSORY

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code KNO·July 16, 2013

    UNKNOWN BI-MENTUM HIP ACETABULAR LINER

    FDA Adverse Event
    Injury ·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code MEH·January 23, 2025

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025