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

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    TENSOR® Suture Button System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·October 21, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 19, 2024

    DURASUL BIPOLAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPAT ENTERAL DELIVERY PUMP SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    UNK - PDL IMPLANT

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code MJO·August 9, 2011

    WAVELIGHT EX500 EXCIMER LASER

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·November 5, 2014

    HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER 6F STANDARD

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code MSD·July 17, 2013

    NUTRILINE

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code LJS·October 30, 2025

    PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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