BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    OsteoFlo HydroFiber

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VASSALLO GT 018 Floppy

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCORD Cable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 6, 2025

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 19, 2025

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC·Product code NBW·November 25, 2008

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 11, 2014

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·July 23, 2013

    PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 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

    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·May 7, 2014

    ACCOLADE DR SL MRI (Model L311)

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